Rule2025-18103
Schedules of Controlled Substances: Placement of Seven Specific Fentanyl-Related Substances in Schedule I
Primary source
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Published
September 18, 2025
Effective
September 18, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration places seven fentanyl- related substances, as identified in this final rule, including their isomers, esters, ethers, salts and salts of isomers, esters and ethers in schedule I of the Controlled Substances Act. The regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these seven specific controlled substances will continue to apply as a result of this action.
Full Text
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<title>Federal Register, Volume 90 Issue 179 (Thursday, September 18, 2025)</title>
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[Federal Register Volume 90, Number 179 (Thursday, September 18, 2025)]
[Rules and Regulations]
[Pages 44979-44984]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18103]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1457]
Schedules of Controlled Substances: Placement of Seven Specific
Fentanyl-Related Substances in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration places seven fentanyl-
related substances, as identified in this final rule, including their
isomers, esters, ethers, salts and salts of isomers, esters and ethers
in schedule I of the Controlled Substances Act. The regulatory controls
and administrative, civil, and criminal sanctions applicable to
schedule I controlled substances on persons who handle (manufacture,
distribute, import, export, engage in research, conduct instructional
activities or chemical analysis, or possess), or propose to handle
these seven specific controlled substances will continue to apply as a
result of this action.
DATES: Effective September 18, 2025.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: In this final rule, the Drug Enforcement
Administration (DEA) permanently schedules the following seven
controlled substances in schedule I of the Controlled Substances Act
(CSA), including their isomers, esters, ethers, salts, and salts of
isomers, esters, and
[[Page 44980]]
ethers whenever the existence of such isomers, esters, ethers, and
salts is possible within the specific chemical designation:
<bullet> para-chlorofentanyl (N-(4-chlorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
<bullet> ortho-chlorofentanyl (N-(2-chlorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
<bullet> meta-fluorofuranyl fentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
<bullet> ortho-methylcyclopropyl fentanyl (N-(2-methylphenyl)-N-(1-
phenethylpiperidin-4-yl)cyclopropanecarboxamide),
<bullet> beta-methylacetyl fentanyl (N-phenyl-N-(1-(2-
phenylpropyl)piperidin-4-yl)acetamide),
<bullet> tetrahydrothiofuranyl fentanyl (N-(1-phenethylpiperidin-4-
yl)-N-phenyltetrahydrothiophene-2-carboxamide),
<bullet> para-fluoro valeryl fentanyl (N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)pentanamide).
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General (delegated to the Administrator of
DEA pursuant to 28 CFR 0.100) on her own motion, at the request of the
Secretary of Health and Human Services (HHS), or on the petition of an
interested party.\1\ This action is supported by, inter alia, a
recommendation from the then-Assistant Secretary for Health of HHS
(Assistant Secretary for HHS or Assistant Secretary) and an evaluation
of all other relevant data by DEA. This action continues the imposition
of the regulatory controls and administrative, civil, and criminal
sanctions of schedule I controlled substances on any person who handles
(manufactures, distributes, imports, exports, engages in research, or
conducts instructional activities or chemical analysis with, or
possesses) or proposes to handle these seven substances.
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\1\ 21 U.S.C. 811(a).
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Background
On February 6, 2018, pursuant to 21 U.S.C. 811(h)(1), DEA published
an order in the Federal Register temporarily placing fentanyl-related
substances, as defined in that order, in schedule I of the CSA based
upon a finding that these substances pose an imminent hazard to the
public safety.\2\ The seven substances named in this final rule meet
the existing definition of fentanyl-related substances as they are not
otherwise controlled in any other schedule (i.e., not included under
another DEA Controlled Substance Code Number) and are structurally
related to fentanyl by one or more of the five modifications listed
under the definition. That temporary order was effective upon the date
of publication.
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\2\ Schedules of Controlled Substances: Temporary Placement of
Fentanyl-Related Substances in Schedule I, 83 FR 5188 (Feb. 6,
2018).
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Pursuant to 21 U.S.C. 811(h)(2), the temporary control of fentanyl-
related substances, a class of substances as defined in the order, as
well as the seven specific substances already covered by that order,
was set to expire on February 6, 2020. However, on February 6, 2020, as
explained in DEA's April 10, 2020, correcting amendment,\3\ Congress
extended that expiration date until May 6, 2021, by enacting the
Temporary Reauthorization and Study of the Emergency Scheduling of
Fentanyl Analogues Act.\4\ This temporary order was subsequently
extended multiple times, most recently on March 15, 2025, which
extended the order until September 30, 2025.\5\ Also, on December 30,
2024, the then-DEA Administrator extended the temporary order in a
separate action.\6\ On the same day, the then-Administrator, on her own
motion pursuant to 21 U.S.C. 811(a), initiated scheduling proceedings
and published a notice of proposed rulemaking (NPRM) to permanently
control these seven specific fentanyl-related substances in schedule I
of the CSA.\7\ Specifically, DEA proposed to add these substances to
the opiates list under 21 CFR 1308.11(b).
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\3\ Schedules of Controlled Substances: Temporary Placement of
Fentanyl-Related Substances in Schedule I; Correction, 85 FR 20155
(Apr. 10, 2020).
\4\ Public Law 116-114, sec. 2, 134 Stat. 103.
\5\ Public Law 119-4, sec. 3105, 139 Stat. 9.
\6\ See Schedules of Controlled Substances: Extension of
Temporary Placement of Seven Specific Fentanyl-Related Substances in
Schedule I of the Controlled Substances Act, 89 FR 106311 (Dec. 30,
2024).
\7\ See Schedules of Controlled Substances: Placement of Seven
Specific Fentanyl-Related Substances in Schedule I, 89 FR 106384
(Dec. 30, 2024). After the publication of the NPRM, Congress enacted
the HALT Fentanyl Act, Public Law 119-26 (July 16, 2025), which,
among other things, permanently places fentanyl-related substances
as a class into schedule I of the CSA.
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DEA and HHS Eight Factor Analyses
On October 25, 2024, the then-Assistant Secretary submitted HHS's
scientific and medical evaluation and scheduling recommendation for
para-chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl and
their salts to the then-Administrator, which recommended placing these
seven specific fentanyl-related substances and their salts in schedule
I of the CSA. In accordance with 21 U.S.C. 811(c), upon receipt of the
scientific and medical evaluation and scheduling recommendation from
HHS, DEA reviewed the documents and all other relevant data and
conducted its own eight-factor analysis of the abuse potential of these
seven fentanyl-related substances.\8\
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\8\ Both the DEA and HHS eight-factor analyses are available in
their entirety under the tab ``Supporting Documents'' of the public
docket for this action at <a href="https://www.regulations.gov">https://www.regulations.gov</a> under Docket
Number ``DEA-1457.''
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Determination To Permanently Schedule Seven Specific Fentanyl-Related
Substances
After review of the available data, including the scientific and
medical evaluation and the scheduling recommendations from HHS, DEA
published an NPRM in the Federal Register on December 30, 2024, which
proposed the placement of seven specific fentanyl-related substances in
schedule I of the CSA.\9\ The NPRM provided an opportunity for
interested persons to file a request for a hearing in accordance with
DEA regulations on or before January 29, 2025. DEA did not receive a
hearing request. The NPRM also provided an opportunity for interested
persons to submit comments on the proposed rule on or before January
29, 2025. DEA did not receive any comment on the proposed rule to
control these seven specific fentanyl-related substances in schedule I
of the CSA.
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\9\ See Schedules of Controlled Substances: Placement of Seven
Specific Fentanyl-Related Substances in Schedule I, 89 FR 106384
(Dec. 30, 2024).
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Scheduling Conclusion
After consideration of the scientific and medical evaluation and
accompanying scheduling recommendation of HHS, and DEA's own eight-
factor analysis, DEA finds that these facts and all relevant data
constitute substantial evidence of potential for abuse for para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl. DEA
is therefore permanently scheduling these seven fentanyl-related
substances as schedule I controlled substances under the CSA.
[[Page 44981]]
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V, and outlines the findings required
to place a drug or other substance in any particular schedule.\10\
After consideration of the analysis and recommendation of the then-
Assistant Secretary for HHS and review of all other available data, the
Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C.
812(b)(1), finds that:
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\10\ 21 U.S.C. 812(b).
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(1) para-Chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl
fentanyl, ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl,
similar to morphine and fentanyl, are mu-opioid receptor agonists.
These seven fentanyl-related substances have analgesic effects that are
mediated by mu-opioid receptor agonism. Substances that produce mu-
opioid receptor agonist effects in the central nervous system are
considered as having a high potential for abuse (e.g., morphine and
fentanyl). Pharmacological data obtained from drug discrimination
studies on these seven fentanyl-related substances show they fully
substituted for the discriminative stimulus effects of morphine.
(2) There is no Food and Drug Administration (FDA)-approved drug
application for para-chlorofentanyl, ortho-chlorofentanyl, meta-
fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, or para-fluoro
valeryl fentanyl in the United States. Further, there are no adequate
and well-controlled clinical studies for any of these substances, and
there are no well-defined finished dosage forms for any of these
fentanyl-related substances. There are no known therapeutic
applications for these seven fentanyl-related substances, and thus they
have no currently accepted medical use in the United States.\11\
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\11\ Pursuant to 21 U.S.C 812(b)(1)(B), when placing a drug or
substance in schedule I of the CSA, DEA must consider whether the
substance has a currently accepted medical use in treatment in the
United States. First, DEA looks to whether the drug or substance has
FDA approval. When no FDA approval exists, DEA has traditionally
applied a five-part test to a drug or substance to determine whether
a drug or substance has a currently medical use: i. the drug's
chemistry must be known and reproducible; ii. there must be adequate
safety studies; iii. there must be adequate and well-controlled
studies proving efficacy; iv. the drug must be accepted by qualified
experts; and v. the scientific evidence must be widely available.
Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR
10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C.
Cir. 1994). DEA applied the traditional five-part test and concluded
the test was not satisfied. In a recent published letter in a
different context, HHS applied an additional two-part test to
determine currently accepted medical use for substances that do not
satisfy the five-part test: (1) whether there exists widespread,
current experience with medical use of the substance by licensed
health care providers operating in accordance with implemented
jurisdiction-authorized programs, where medical use is recognized by
entities that regulate the practice of medicine, and, if so, (2)
whether there exists some credible scientific support for at least
one of the medical conditions for which part (1) is satisfied. On
April 11, 2024, the Department of Justice's Office of Legal Counsel
(OLC) issued an opinion, which, among other things, concluded that
HHS's two-part test would be sufficient to establish that a drug has
a currently accepted medical use. Office of Legal Counsel,
Memorandum for Merrick B. Garland Attorney General Re: Questions
Related to the Potential Rescheduling of Marijuana at 3 (April 11,
2024). In its eight-factor assessment, HHS determined that these
seven fentanyl-related substances did not satisfy this two-part
test. Therefore, since both DEA and HHS have determined that these
seven fentanyl-related substances do not satisfy the five-part test,
and HHS has determined that these seven fentanyl-related substances
do not satisfy the additional two-part test, DEA concludes that
para-chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl
fentanyl, ortho-methylcyclopropyl fentanyl, beta-methylacetyl
fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl
fentanyl do not have a currently accepted medical use.
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(3) There is a lack of accepted safety for use of para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl under
medical supervision. Because these seven substances have no FDA-
approved medical use and have not been investigated as new drugs, their
safety for use under medical supervision has not been determined.
Therefore, there is a lack of accepted safety for use of these seven
substances under medical supervision.
Based on these findings, the Administrator of DEA concludes that
para-chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl,
including their isomers, esters, ethers, salts, and salts of isomers,
esters, and ethers whenever the existence of such isomers, esters,
ethers, and salts is possible within the specific chemical designation,
warrant continued control in schedule I of the CSA.\12\
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\12\ 21 U.S.C. 812(b)(1).
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Requirements for Handling para-Chlorofentanyl, ortho-Chlorofentanyl,
meta-Fluorofuranyl fentanyl, ortho-Methylcyclopropyl fentanyl, beta-
Methylacetyl fentanyl, Tetrahydrothiofuranyl fentanyl, and para-Fluoro
valeryl fentanyl
As discussed above, these seven fentanyl-related substances are
currently subject to a temporary scheduling order, which added them to
schedule I. para-Chlorofentanyl, ortho-chlorofentanyl, meta-
fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro
valeryl fentanyl will continue to be subject to the CSA's schedule I
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, dispensing, importing,
exporting, research, and conduct of instructional activities, including
the following:
1. Registration. Any person who handles (manufactures, distributes,
dispenses, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl must
be registered with DEA to conduct such activities pursuant to 21 U.S.C.
822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and
1312. Retail sales of schedule I controlled substances to the general
public are not allowed under the CSA. Possession of any quantity of
these substances in a manner not authorized by the CSA is unlawful and
those in possession of any quantity of these substances may be subject
to prosecution pursuant to the CSA.
2. Disposal of stocks. para-Chlorofentanyl, ortho-chlorofentanyl,
meta-fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro
valeryl fentanyl must be disposed of in accordance with 21 CFR part
1317, in addition to all other applicable federal, state, local, and
tribal laws.
3. Security. para-Chlorofentanyl, ortho-chlorofentanyl, meta-
fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro
valeryl fentanyl are subject to schedule I security requirements and
must be handled and stored pursuant to
[[Page 44982]]
21 U.S.C. 821, 823, and in accordance with 21 CFR 1301.71 through
1301.76. Non-practitioners handling these seven substances also must
comply with the screening requirements of 21 CFR 1301.90 through
1301.93.
4. Labeling and Packaging. All labels and labeling for commercial
containers of para-chlorofentanyl, ortho-chlorofentanyl, meta-
fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro
valeryl fentanyl must comply with 21 U.S.C. 825 and 958(e) and be in
accordance with 21 CFR part 1302.
5. Quota. Only registered manufacturers are permitted to
manufacture para-chlorofentanyl, ortho-chlorofentanyl, meta-
fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro
valeryl fentanyl in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21 CFR part 1303.
6. Inventory. Any person registered with DEA to handle para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl must
have an initial inventory of all stocks of controlled substances
(including these substances) on hand on the date the registrant first
engages in the handling of controlled substances pursuant to 21 U.S.C.
827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11. After the initial inventory, every DEA registrant must take a
new inventory of all stocks of controlled substances (including para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl) on
hand every two years pursuant to 21 U.S.C. 827 and 958(e) and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to para-chlorofentanyl, ortho-
chlorofentanyl, meta-fluorofuranyl fentanyl, ortho-methylcyclopropyl
fentanyl, beta-methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl,
and para-fluoro valeryl fentanyl, pursuant to 21 U.S.C. 827, 832(a),
and 958(e), and in accordance with 21 CFR 1301.74(b) and (c) and
1301.76(b) and parts 1304, 1312, and 1317. Manufacturers and
distributors would be required to submit reports regarding para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl to the
Automation of Reports and Consolidated Order System pursuant to 21
U.S.C. 827, and in accordance with 21 CFR parts 1304 and 1312.
8. Order Forms. Every DEA registrant who distributes para-
chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl must
comply with the order form requirements, pursuant to 21 U.S.C. 828 and
21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of
para-chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl fentanyl,
ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl must
be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in
accordance with 21 CFR part 1312.
10. Liability. Any activity involving para-chlorofentanyl, ortho-
chlorofentanyl, meta-fluorofuranyl fentanyl, ortho-methylcyclopropyl
fentanyl, beta-methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl,
and para-fluoro valeryl fentanyl not authorized by, or in violation of,
the CSA or its implementing regulations is unlawful, and may subject
the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866, 13563, 14192, and 14294
In accordance with 21 U.S.C. 811(a), this final scheduling action
is subject to formal rulemaking procedures done ``on the record after
opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for
scheduling a drug or other substance. Such actions are exempt from
review by the Office of Management and Budget (OMB) pursuant to section
3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed
in E.O. 13563. DEA scheduling actions are not subject to either E.O.
14192, Unleashing Prosperity Through Deregulations, or E.O. 14294,
Fighting Overcriminalization in Federal Regulations.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the States, on the relationship between the National
Government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-612, has reviewed this rule and by approving it,
certifies that it will not have a significant economic impact on a
substantial number of small entities. On February 6, 2018, DEA
published an order to temporarily place fentanyl-related substances, as
defined in the order, in schedule I of the CSA pursuant to the
temporary scheduling provisions of 21 U.S.C. 811(h). However, as
explained in DEA's April 10, 2020, correcting amendment,\13\ Congress
extended that expiration date until May 6, 2021, by enacting the
Temporary Reauthorization and Study of the Emergency Scheduling of
Fentanyl Analogues Act.\14\ This temporary order was subsequently
extended multiple times, most recently on March 15, 2025, which
extended the order until September 30, 2025.\15\ Also, on December 30,
2024, the then-DEA Administrator extended the temporary
[[Page 44983]]
order to these seven fentanyl-related substances in a separate
action.\16\ Thus, DEA estimates that all entities handling or planning
to handle para-chlorofentanyl, ortho-chlorofentanyl, meta-fluorofuranyl
fentanyl, ortho-methylcyclopropyl fentanyl, beta-methylacetyl fentanyl,
tetrahydrothiofuranyl fentanyl, and para-fluoro valeryl fentanyl have
already established and implemented systems and processes required to
handle these substances which meet the definition of fentanyl-related
substances.
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\13\ Schedules of Controlled Substances: Temporary Placement of
Fentanyl-Related Substances in Schedule I; Correction, 85 FR 20155
(Apr. 10, 2020).
\14\ Public Law 116-114, sec. 2, 134 Stat. 103.
\15\ Public Law 119-4, sec. 3105, 139 Stat. 9.
\16\ See Schedules of Controlled Substances: Extension of
Temporary Placement of Seven Specific Fentanyl-Related Substances in
Schedule I of the Controlled Substances Act, 89 FR 106311 (Dec. 30,
2024).
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There are currently 170 registrations authorized to specifically
handle the fentanyl-related substances as a class, which include one or
more of the following substances: para-chlorofentanyl, ortho-
chlorofentanyl, meta-fluorofuranyl fentanyl, ortho-methylcyclopropyl
fentanyl, beta-methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl,
and para-fluoro valeryl fentanyl, as well as a number of registered
analytical labs that are authorized to handle schedule I controlled
substances generally. Some of these entities are likely to be large
entities. However, since DEA does not have information of registrant
size, DEA conservatively assumes all of the 170 registrants affected by
this rule are small entities.
A review of the 170 registrations indicates that all entities that
currently handle para-chlorofentanyl, ortho-chlorofentanyl, meta-
fluorofuranyl fentanyl, ortho-methylcyclopropyl fentanyl, beta-
methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para-fluoro
valeryl fentanyl also handle other schedule I controlled substances and
have established and implemented (or maintained) systems and processes
required to handle these substances. Therefore, DEA anticipates this
final rule will impose minimal or no economic impact on any affected
entities; and thus, will not have a significant economic impact on any
of the 170 affected small entities. Consequently, DEA has concluded
that this final rule will not have a significant economic impact on a
substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies that this
action would not result in any Federal mandate that may result ``in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year. . . .'' Therefore, neither a Small
Government Agency Plan nor any other action is required under the UMRA
of 1995.
Paperwork Reduction Act of 1995
This rule would not impose a new collection or modify an existing
collection of information under the Paperwork Reduction Act of
1995.\17\ Also, this rule would not impose new or modify existing
recordkeeping or reporting requirements on state or local governments,
individuals, businesses, or organizations. However, this rule would
require compliance with the following existing OMB collections: 1117-
0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009, 1117-0010, 1117-0012,
1117-0014, 1117-0021, 1117-0023, 1117-0029, and 1117-0056. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
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\17\ 44 U.S.C. 3501-3521.
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List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In 1308.11:
0
a. Redesignate paragraphs (b)(104) through (110) as paragraphs (b)(111)
through (117);
0
b. Redesignate paragraphs (b)(87) through (103) as paragraphs (b)(93)
through (109);
0
c. Redesignate paragraphs (b)(84) through (86) as paragraphs (b)(89)
through (91);
0
d. Redesignate paragraphs (b)(82) and (83) as paragraphs (b)(86) and
(87);
0
e. Redesignate paragraphs (b)(76) through (81) as paragraphs (b)(79)
through (84);
0
f. Redesignate paragraphs (b)(59) through (75) as paragraphs (b)(61)
through (77);
0
g. Redesignate paragraphs (b)(21) through (58) as paragraphs (b)(22)
through (59);
0
h. Add new paragraphs (b)(21), (60), (78), (85), (88), (92), and (110);
and
0
i. Remove and reserve paragraphs h(70) through h(76).
The additions to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(21) beta-methylacetyl fentanyl (N-phenyl-N-(1-(2- 9868
phenylpropyl)piperidin-4-yl)acetamide).................
* * * * * * *
(60) meta-fluorofuranyl fentanyl (N-(3-fluorophenyl)-N- 9871
(1-phenethylpiperidin-4-yl)furan-2-carboxamide)........
* * * * * * *
(78) ortho-chlorofentanyl (N-(2-chlorophenyl)-N-(1- 9828
phenethylpiperidin-4-yl)propionamide...................
* * * * * * *
(85) ortho-methylcyclopropyl fentanyl (N-(2- 9849
methylphenyl)-N-(1-phenethylpiperidin-4-
yl)cyclopropanecarboxamide)............................
* * * * * * *
(88) para-chlorofentanyl (N-(4-chlorophenyl)-N-(1- 9818
phenethylpiperidin-4-yl)propionamide)..................
* * * * * * *
(92) para-fluoro valeryl fentanyl (N-(4-fluorophenyl)-N- 9870
(1-phenethylpiperidin-4-yl)pentanamide)................
[[Page 44984]]
* * * * * * *
(110) tetrahydrothiofuranyl fentanyl (also known as: 9869
tetrahydrothiophene fentanyl) (N-(1-phenethylpiperidin-
4-yl)-N-phenyltetrahydrothiophene-2-carboxamide).......
* * * * * * *
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 8, 2025, by Administrator Terrance Cole. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-18103 Filed 9-17-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 18, 2025.
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