Rule2023-26694
Schedules of Controlled Substances: Placement of Nine Specific Fentanyl-Related Substances in Schedule I
Primary source
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Published
December 7, 2023
Effective
December 7, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration places nine fentanyl-related substances, as identified in this final rule, 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, in schedule I of the Controlled Substances Act. These nine fentanyl-related substances are currently listed in schedule I pursuant to a temporary scheduling order. This action makes permanent the imposition of 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 with, or possess), or propose to handle these nine specific fentanyl-related controlled substances.
Full Text
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<title>Federal Register, Volume 88 Issue 234 (Thursday, December 7, 2023)</title>
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[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Rules and Regulations]
[Pages 85104-85109]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26694]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1036]
Schedules of Controlled Substances: Placement of Nine Specific
Fentanyl-Related Substances in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: With the issuance of this final rule, the Drug Enforcement
Administration places nine fentanyl-related substances, as identified
in this final rule, 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, in schedule I of the
Controlled Substances Act. These nine fentanyl-related substances are
currently listed in schedule I pursuant to a temporary scheduling
order. This action makes permanent the imposition of 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 with, or possess), or propose to handle
these nine specific fentanyl-related controlled substances.
DATES: Effective date: December 7, 2023.
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 rule, the Drug Enforcement
Administration (DEA) is permanently scheduling the following nine
controlled substances 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, in schedule I of the
Controlled Substances Act (CSA):
<bullet> meta-fluorofentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide),
<bullet> meta-fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide),
<bullet> para-methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
<bullet> 3-furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylfuran-3-carboxamide),
<bullet> 2',5'-dimethoxyfentanyl (N-(1-(2,5-
dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide),
<bullet> isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-
yl)-N-phenylbutanamide),
<bullet> ortho-fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)furan-2-carboxamide),
<bullet> alpha'-methyl butyryl fentanyl (2-methyl-N-(1-
phenethylpiperidin-4-yl)-N-phenylbutanamide), and
<bullet> para-methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1-
phenethylpiperidin-4-yl)cyclopropanecarboxamide).
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 (1) on his own motion; (2) at the
request of the Secretary of the Department of Health and Human Services
(HHS); \1\ or (3) on the petition of any interested party.\2\ This
action was initiated on the Attorney General's own motion, as delegated
to the Administrator of the DEA (Administrator), and is supported by,
inter alia, a recommendation from the Assistant Secretary for Health of
HHS
[[Page 85105]]
(Assistant Secretary) and an evaluation of all 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 or proposes to handle meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl.
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\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in
carrying out the Secretary's scheduling responsibilities under the
CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The
Secretary of HHS has delegated to the Assistant Secretary for Health
of HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
\2\ 21 U.S.C. 811(a).
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Background
On February 6, 2018, DEA published an order in the Federal Register
(FR) (83 FR 5188) amending 21 CFR 1308.11(h), 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 and pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). The nine 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 scheduling
order was effective on the date of publication and was based on
findings by the former Acting Administrator that the temporary
scheduling of these substances was necessary to avoid an imminent
hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). 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
these nine 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 (85 FR 20155),
Congress extended that expiration date until May 6, 2021, by enacting
the Temporary Reauthorization and Study of the Emergency Scheduling of
Fentanyl Analogues Act (Pub. L. 116-114, sec. 2, 134 Stat. 103). This
temporary order was subsequently extended multiple times, most recently
on December 29, 2022, through the Consolidated Appropriations Act,
2023, which extended the order until December 31, 2024.
Comment: One commenter stated that fentanyl and the list of related
substances is a hazard due to the overdose deaths that have been
occurring. This commenter also referenced the National Institute on
Drug Abuse, stating that fentanyl-related overdoses have been
increasing in the United States. Lastly, this commenter stated that
permanently placing fentanyl and the list of related substances in
schedule I would improve public health and allow for regulation of
these substances.
DEA Response: DEA appreciates the comments in support of this
rulemaking. One clarification to note is that fentanyl remains a
schedule II substance. This final rule only applies to the fentanyl-
related substances that are listed in this final order.
Comment: One commenter stated the proposed rule would make it more
difficult to produce and distribute these dangerous fentanyl-related
substances, which would help combat the opioid epidemic in the United
States. This commenter also referenced a news article by National
Public Radio, stating that these nine fentanyl-related substances are
not currently classified as controlled substances, making it easy to
produce and distribute these substances without legal consequences.
Lastly, this commenter recognized that this proposal could have
significant impacts on the healthcare industry, such as increased
oversight and regulation of fentanyl-related substances, which could
prevent their misuse and abuse.
DEA Response: DEA appreciates the comments in support of this
rulemaking. One clarification to note based on the comment above is
that, by temporary order on February 6, 2018, DEA placed these nine
fentanyl-related substances under schedule I. 83 FR 5188. That
temporary order defined a fentanyl-related substance to mean any
substance not otherwise controlled in any schedule (i.e., not listed
under another DEA 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 five specified structural
modifications. Therefore, these nine fentanyl-related substances are in
fact already schedule I controlled substances.
The final rule being issued today applies to nine fentanyl-related
substances that were the subject of a February 6, 2018, temporary
scheduling order. These nine substances will now be listed in 21 CFR
1308.11(b), as specified in the text of the rule that appears below.
This final rule should not have a significant impact on the healthcare
industry because these nine fentanyl-related substances have no medical
use and they have already been added as schedule I controlled
substances since 2018.
Comment: One commenter discussed the direct and indirect effects on
federal and state healthcare from this regulation. The commenter
suggested that this regulation will boost federal oversight of
manufacturing and disseminating harmful chemicals. In addition, this
regulation would limit availability and expected use, ensure protection
of residents, and increases confidence in the medical field. In
addition, the commenter stated that is critical to restrict the use of
``fentanyl replicates'' to those who may need them for medical
conditions. Lastly, the commenter stated that raising awareness of the
risks of abusing these drugs benefits their prevention.
DEA Response: DEA appreciates the comments in support of this
rulemaking. As mentioned previously, FDA has not approved a marketing
application for a drug product containing any of these nine substances
for any therapeutic indication. These substances have no medical use in
the United States.
Comment: One commenter stated that this rule will affect federal
healthcare because many federal agencies are trying to tackle the
opioid crisis. The commenter discussed the rising number of pediatric
deaths from fentanyl in 2021 and the surge in 2018 of fentanyl
overdoses among older adolescents as well as in children younger than
five. The commenter agrees with this final rule to schedule these
fentanyl-related substances. The commenter also stated that fentanyl is
highly addictive and that while fentanyl is prescribed for chronic pain
or major surgery, it should be a last resort.
DEA Response: DEA appreciates the comments in support of this
rulemaking.
Comment: One commenter agreed with this final rule to make
permanent these nine specific fentanyl-related substances rather than
continuing multiple temporary extensions. Once finalized, the commenter
stated that the federal government could act against anyone handling
these substances since over 150 people die each day from a fentanyl-
related drug overdose.
DEA Response: DEA appreciates the comments in support of this
rulemaking. Again, DEA notes that fentanyl is a schedule II controlled
substance that can be prescribed for approved medical uses. However,
the nine fentanyl-related substances addressed in this rule are already
[[Page 85106]]
schedule I controlled substances and none of them have any medical use
in the United States.
Comment: One commenter stated that fentanyl should be placed in
schedule I. The commenter compared this substance to marijuana, which
is a schedule I drug and thought it was mind-blowing that fentanyl was
not a schedule I substance. It was suggested that the rising number of
deaths, the risk to public health, abuse potential, and dependency
should classify fentanyl as a schedule I.
DEA Response: DEA appreciates this comment. As stated previously,
fentanyl remains a schedule II substance. Fentanyl has approved medical
uses in the United States. This final rule only applies to the
fentanyl-related substances that are listed in this final order.
Scheduling Conclusion
After consideration of the relevant matter presented through public
comments, the scientific and medical evaluation and accompanying
recommendation of HHS, and after its own eight-factor evaluation, DEA
finds that these facts and all other relevant data constitute
substantial evidence of the potential for abuse of meta-fluorofentanyl,
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl. DEA is permanently scheduling these nine
fentanyl-related substances as schedule I controlled substances under
the CSA.
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also specifies the findings
required to place a drug or other substance in any particular
schedule.\3\ After consideration of the analysis and recommendation of
the Assistant Secretary for HHS and review of all other available data,
the Administrator, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds
the following:
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\3\ 21 U.S.C. 812(b).
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(1) The abuse potential of meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl is associated with each substance's
pharmacological similarity to other schedule I and II mu-opioid
receptor agonist substances which have a high potential for abuse.
Similar to morphine (schedule II), fentanyl (schedule II), and several
schedule I opioid substances that are structurally related to fentanyl,
these nine fentanyl-related substances have been shown to bind and act
as mu-opioid receptor agonists;
(2) meta-Fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl
butyryl fentanyl, and para-methylcyclopropyl fentanyl, have no
currently accepted medical use in treatment in the United States; \4\
and
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\4\ Although there is no evidence suggesting that meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl
fentanyl, and para-methylcyclopropyl fentanyl have a currently
accepted medical use in treatment in the United States, it bears
noting that a drug cannot be found to have such medical use unless
DEA concludes that it satisfies a five-part test. Specifically, with
respect to a drug that has not been approved by FDA, to have a
currently accepted medical use in treatment in the United States,
all of the following must be demonstrated:
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.
57 FR 10499 (1992).
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(3) There is a lack of accepted safety for use of meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl under medical supervision.
Based on these findings, the Administrator concludes that meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl 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,
warrant control in schedule I of the CSA.\5\
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\5\ 21 U.S.C. 812(b)(1).
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This final rule does not affect the scheduling of fentanyl itself,
which remains a schedule II controlled substance.
Requirements for Handling Meta-Fluorofentanyl, Meta-Fluoroisobutyryl
Fentanyl, Para-Methoxyfuranyl Fentanyl, 3-Furanyl Fentanyl, 2',5'-
Dimethoxyfentanyl, Isovaleryl Fentanyl, Ortho-Fluorofuranyl Fentanyl,
Alpha'-Methyl Butyryl Fentanyl, and Para-Methylcyclopropyl Fentanyl
Meta-Fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl
butyryl fentanyl, and para-methylcyclopropyl fentanyl will continue, on
a permanent basis,\6\ 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:
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\6\ meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl
fentanyl, alpha'-methyl butyryl fentanyl, and/or para-
methylcyclopropyl fentanyl have been subject to schedule I controls
on a temporary basis, pursuant to 21 U.S.C. 811(h), by virtue of the
February 6, 2018 temporary scheduling order (83 FR 5188) and the
subsequent statutory extension of that order through December 31,
2024 (Pub. L. 117-328, Division O, Title VI, Sec. 601).
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1. Registration. Any person who handles (manufactures, distributes,
dispenses, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl, or who desires to handle these
nine substances, is required to 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. meta-fluorofentanyl, meta-fluoroisobutyryl
fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
[[Page 85107]]
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl,
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl 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. meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl,
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl,
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl are
subject to schedule I security requirements and must be handled and
stored pursuant to 21 U.S.C. 823, and in accordance with 21 CFR
1301.71-1301.76. Non-practitioners handling these nine substances must
also comply with the employee screening requirements of 21 CFR 1301.90-
1301.93.
4. Labeling and Packaging. All labels and labeling for commercial
containers of meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl,
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl,
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl,
must be in compliance with 21 U.S.C. 825, and be in accordance with 21
CFR part 1302.
5. Quota. Only registered manufacturers are permitted to
manufacture meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl
butyryl fentanyl, and para-methylcyclopropyl 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 meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl 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 meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl 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 meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl, pursuant to 21 U.S.C. 827 and 958(e), and
in accordance with 21 CFR parts 1301.74(b) and (c), 1301.76(b), 1307.11
and parts 1304, 1312, and 1317. Manufacturers and distributors must
submit reports regarding these substances 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 meta-
fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl
fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl
fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl,
and para-methylcyclopropyl fentanyl must continue to comply with the
order form requirements, pursuant to 21 U.S.C. 828 and in accordance
with 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of
meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl, para-
methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-dimethoxyfentanyl,
isovaleryl fentanyl, ortho-fluorofuranyl fentanyl, alpha'-methyl
butyryl fentanyl, and para-methylcyclopropyl fentanyl must comply with
21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part
1312.
10. Liability. Any activity involving meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl 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 (E.O.) 12866 (Regulatory Planning and Review), 13563
(Improving Regulation and Regulatory Review), and 14094 (Modernizing
Regulatory Review)
This action is not a significant regulatory action as defined by
Executive Order (E.O.) 12866 (Regulatory Planning and Review), section
3(f), and the principles reaffirmed in E.O. 13563 (Improving Regulation
and Regulatory Review); and, accordingly, this action has not been
reviewed by the Office of Management and Budget (OMB). This action
makes no change in the status quo, as meta-fluorofentanyl, meta-
fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl are already listed as a schedule I
controlled substances.
Executive Order 12988, Civil Justice Reform
This action 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. 601-602, has reviewed this final rule and, by approving
it, certifies that it will not have a significant economic impact on a
substantial number of small
[[Page 85108]]
entities. On February 6, 2018, DEA published an order to temporarily
place fentanyl-related substances in schedule I of the CSA pursuant to
the temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates
that all entities handling or planning to handle meta-fluorofentanyl,
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl have already established and implemented the
systems and processes required to handle these substances.
As discussed in the NPRM, there are 108 registrations authorized to
handle one or more of the following substances: meta-fluorofentanyl,
meta-fluoroisobutyryl fentanyl, para-methoxyfuranyl fentanyl, 3-furanyl
fentanyl, 2',5'-dimethoxyfentanyl, isovaleryl fentanyl, ortho-
fluorofuranyl fentanyl, alpha'-methyl butyryl fentanyl, and para-
methylcyclopropyl fentanyl, as well as a number of registered
analytical labs that are authorized to handle schedule I controlled
substances generally. These 108 registrations represent a maximum of 95
small entities. Therefore, DEA conservatively estimates as many as 95
small entities are affected by this rule.
A review of the 108 registrations indicates that all entities that
currently handle meta-fluorofentanyl, meta-fluoroisobutyryl fentanyl,
para-methoxyfuranyl fentanyl, 3-furanyl fentanyl, 2',5'-
dimethoxyfentanyl, isovaleryl fentanyl, ortho-fluorofuranyl fentanyl,
alpha'-methyl butyryl fentanyl, and para-methylcyclopropyl fentanyl,
also handle other schedule I controlled substances and have established
and implemented (or maintain) the systems and processes required to
handle these substances. Therefore, DEA anticipates that 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 small entities. Therefore, 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 million or more (adjusted annually
for inflation) in any 1 year * * * .'' Therefore, neither a Small
Government Agency Plan nor any other action is required under UMRA of
1995.
Paperwork Reduction Act of 1995
This final rule does not impose a new collection or modify an
existing collection of information under the Paperwork Reduction Act of
1995. 44 U.S.C. 3501-3521. Also, this final rule does not impose new or
modify existing recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or organizations. However,
this final rule does 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.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. Pursuant to the CRA, DEA is submitting
a copy of this final rule to both Houses of Congress and to the
Comptroller General.
Determination To Make Rule Effective Immediately
As indicated above, this rule finalizes the schedule I control
status of nine substances that has already been in effect. These nine
substances all fall within the definition of fentanyl-related
substances set forth in the February 6, 2018, temporary scheduling
order (83 FR 5188). Through the Temporary Reauthorization and Study of
the Emergency Scheduling of Fentanyl Analogues Act, which became law on
February 6, 2020, Congress extended the temporary control of fentanyl-
related substances until May 6, 2021. This temporary order was
subsequently extended multiple times, most recently on December 29,
2022, through the Consolidated Appropriations Act, 2023, which extended
the order until December 31, 2024.\7\ The February 2018 order was
effective on the date of publication, and was based on findings by the
then-Acting Administrator that the temporary scheduling of the
fentanyl-related substances was necessary to avoid an imminent hazard
to the public safety pursuant to 21 U.S.C. 811(h)(1). Because this rule
finalizes the control status of nine substances that has already been
in effect, it does not alter the legal obligations of any person who
handles these substances. Rather, it merely makes permanent the current
scheduling status and corresponding legal obligations. Therefore, since
this rule does not change the current scheduling status and
corresponding legal obligations, DEA is making the rule effective on
the date of publication in the Federal Register, as any delay in the
effective date is unnecessary and would be contrary to the public
interest.
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\7\ Public Law 117-328, Division O, Title VI, Sec. 601.
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Signing Authority
This document of the Drug Enforcement Administration was signed on
November 29, 2023, by Administrator Anne Milgram. 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.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
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, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Redesignate paragraphs (b)(10) through (94) to read as follows:
------------------------------------------------------------------------
Old paragraph New paragraph
------------------------------------------------------------------------
(b)(10) through (33)...................... (b)(11) through (34).
(b)(34) through (43)...................... (b)(36) through (45).
(b)(44) through (47)...................... (b)(47) through (50).
(b)(48) through (50)...................... (b)(52) through (54).
(b)(51) through (66)...................... (b)(57) through (72).
(b)(67) through (74)...................... (b)(74) through (81).
(b)(75) through (94)...................... (b)(84) through (103).
------------------------------------------------------------------------
0
b. Add new paragraphs (b)(10), (35), (46), (51), (55), (56), (73),
(82), and (83);
The additions to read as follows:
[[Page 85109]]
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
* * * * * * *
(10) alpha'-Methyl butyryl fentanyl (2-methyl-N-(1- 9864
phenethylpiperidin-4-yl)-N-phenylbutanamide)....................
* * * * * * *
(35) 2',5'-Dimethoxyfentanyl (N-(1-(2,5- 9861
dimethoxyphenethyl)piperidin-4-yl)-N-phenylpropionamide)........
* * * * * * *
(46) 3-Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9860
phenylfuran-3-carboxamide)......................................
* * * * * * *
(51) Isovaleryl fentanyl (3-methyl-N-(1-phenethylpiperidin-4-yl)- 9862
N-phenylbutanamide).............................................
* * * * * * *
(55) meta-Fluorofentanyl (N-(3-fluorophenyl)-N-(1- 9857
phenethylpiperidin-4-yl)propionamide)...........................
(56) meta-Fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-N-(1- 9858
phenethylpiperidin-4-yl)isobutyramide)..........................
* * * * * * *
(73) ortho-Fluorofuranyl fentanyl (N-(2-fluorophenyl)-N-(1- 9863
phenethylpiperidin-4-yl)furan-2-carboxamide)....................
* * * * * * *
(82) para-Methoxyfuranyl fentanyl (N-(4-methoxyphenyl)-N-(1- 9859
phenethylpiperidin-4-yl)furan-2-carboxamide.....................
(83) para-Methylcyclopropyl fentanyl (N-(4-methylphenyl)-N-(1- 9865
phenethylpiperidin-4-yl)cyclopropanecarboxamide)................
* * * * *
[FR Doc. 2023-26694 Filed 12-6-23; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on December 7, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.