Rule2021-12261
Schedules of Controlled Substances: Placement of N-Ethylpentylone in Schedule I
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Published
June 14, 2021
Effective
June 14, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration places 1-(1,3-benzodioxol- 5-yl)-2-(ethylamino)pentan-1-one (known as N-ethylpentylone or ephylone) and its optical, positional, and geometric isomers, salts, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action makes permanent the current imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle N-ethylpentylone.
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<title>Federal Register, Volume 86 Issue 112 (Monday, June 14, 2021)</title>
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[Federal Register Volume 86, Number 112 (Monday, June 14, 2021)]
[Rules and Regulations]
[Pages 31427-31429]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12261]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules
and Regulations
[[Page 31427]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-482]
Schedules of Controlled Substances: Placement of N-Ethylpentylone
in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration places 1-(1,3-benzodioxol-
5-yl)-2-(ethylamino)pentan-1-one (known as N-ethylpentylone or
ephylone) and its optical, positional, and geometric isomers, salts,
and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible, in schedule I of the Controlled
Substances Act. This action makes permanent the current imposition of
the regulatory controls and administrative, civil, and criminal
sanctions applicable to schedule I controlled substances on persons who
handle (manufacture, distribute, reverse distribute, import, export,
engage in research, conduct instructional activities or chemical
analysis, or possess), or propose to handle N-ethylpentylone.
DATES: Effective date: June 14, 2021.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-8207.
SUPPLEMENTARY INFORMATION:
Legal Authority
The Controlled Substances Act (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. 21 U.S.C. 811(a). This action was initiated on the Attorney
General's own motion, as delegated to the Administrator of the Drug
Enforcement Administration (DEA), and it is supported by a
recommendation from the Assistant Secretary for Health of HHS
(Assistant Secretary) and an evaluation of all other relevant data by
DEA. This action makes permanent the current, temporary imposition of
regulatory controls and administrative, civil, and criminal sanctions
for schedule I controlled substances on any person who handles or
proposes to handle N-ethylpentylone.
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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.
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Background
On August 31, 2018, DEA published an order in the Federal Register
amending 21 CFR 1308.11(h) to temporarily place 1-(1,3-benzodioxol-5-
yl)-2-(ethylamino)pentan-1-one (known as N-ethylpentylone or ephylone)
in schedule I of the CSA pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). 83 FR 44474. That temporary scheduling
order was effective on the date of publication, and was based on
findings by the Acting Administrator of DEA that the temporary
scheduling of this synthetic cathinone was necessary to avoid an
imminent hazard to the public safety pursuant to section 811(h)(1). On
August 27, 2020, DEA published an order to extend the temporary
scheduling of N-ethylpentylone by one year, or until August 31, 2021,
pursuant to section 811(h)(2). 85 FR 52915. Also, on that same date and
in the same issue of the Federal Register, DEA simultaneously published
a notice of proposed rulemaking (NPRM) to permanently control N-
ethylpentylone in schedule I of the CSA. 85 FR 52935. Specifically, DEA
proposed to add N-ethylpentylone to the hallucinogenic substances list
under 21 CFR 1308.11(d).
DEA and HHS Eight Factor Analyses
On July 15, 2020, HHS provided DEA with a scientific and medical
evaluation document prepared by the Food and Drug Administration (FDA)
entitled ``Basis for the Recommendation to Control N-ethylpentylone and
Its Optical, Geometric, and Positional Isomers, Salts, and Salts of
Isomers in Schedule I of the Controlled Substances Act.'' After
considering the eight factors in 21 U.S.C. 811(c) pursuant to 21 U.S.C.
811(b), and N-ethylpentylone's abuse potential, lack of legitimate
medical use in the United States, and lack of accepted safety for use
under medical supervision pursuant to 21 U.S.C. 812(b), the Assistant
Secretary recommended that N-ethylpentylone be controlled in schedule I
of the CSA.
In response, DEA conducted its own eightfactor analysis of N-
ethylpentylone under 21 U.S.C. 811(c), and concluded that this
substance warrants control in schedule I of the CSA, as it meets the
findings prescribed by 21 U.S.C. 812(b)(1). Both DEA and HHS eight-
factor analyses are available in their entirety in the public docket
for this rule (Docket Number DEA-482) at <a href="http://www.regulations.gov">http://www.regulations.gov</a>
under ``Supporting Documents.''
Determination to Schedule N-Ethylpentylone
After a review of the available data, including the scientific and
medical evaluation and the scheduling recommendation from HHS, DEA
published an NPRM entitled ``Schedules of Controlled Substances:
Placement of N-ethylpentylone in Schedule I.'' This rule proposed to
control N-ethylpentylone, and its optical, positional, and geometric
isomers, salts, and salts of isomers in schedule I of the CSA. 85 FR
52935, August 27, 2020. The NPRM provided an opportunity for interested
persons to file a request for hearing in accordance with DEA
regulations on or before September 28, 2020. No requests for such a
hearing were received by DEA. The NPRM also provided an opportunity for
interested persons to submit comments on the proposed rule on or before
September 28, 2020.
Comment Received
DEA received one anonymous comment on the proposed rule to control
N-ethylpentylone in schedule I
[[Page 31428]]
of the CSA. However, this comment was not related to the rule;
therefore, DEA does not respond to the comment.
Scheduling Conclusion
After consideration of the relevant matter presented through the
scientific and medical evaluation and the accompanying scheduling
recommendation of HHS, and after its own eight-factor evaluation, DEA
finds that these facts and all other relevant data constitute
substantial evidence of potential for abuse of N-ethylpentylone.
Accordingly, DEA is permanently scheduling N-ethylpentylone as a
controlled substance 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 outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the Assistant Secretary and review of all other
available data, the Acting Administrator, pursuant to 21 U.S.C. 811(a)
and 812(b)(1), finds that:
(1) N-Ethylpentylone has a high potential for abuse;
(2) N-Ethylpentylone has no currently accepted medical use in
treatment in the United States; \2\ and
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\2\ Although there is no evidence suggesting that N-
ethylpentylone has 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), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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(3) There is a lack of accepted safety for use of N-ethylpentylone
under medical supervision.
Based on these findings, the Acting Administrator concludes that 1-
(1,3-benzodioxol-5-yl)-2-(ethylamino)pentan-1-one (known as N-
ethylpentylone or ephylone) and its optical, positional, and geometric
isomers, including its salts, isomers, and salts of isomers, whenever
the existence of such salts, isomers, and salts of isomers is possible,
warrants continued control in schedule I of the CSA. 21 U.S.C.
812(b)(1).
Requirements for Handling N-Ethylpentylone
N-Ethylpentylone will continue \3\ to be subject to the CSA's
schedule I regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, reverse
distribution, importation, exportation, engagement in research, and
conduct of instructional activities or chemical analysis with, and
possession of schedule I controlled substances including the following:
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\3\ N-Ethylpentylone has been subject to schedule I controls on
a temporary basis, pursuant to 21 U.S.C. 811(h), by virtue of the
August 31, 2018 temporary scheduling order (83 FR 44474) and the
subsequent one-year extension of that order (August 27, 2020, 85 FR
52915).
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1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses) N-
ethylpentylone, or who desires to handle N-ethylpentylone, 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.
2. Security. N-Ethylpentylone is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 821,
823, 871(b), and in accordance with 21 CFR 1301.71-1301.76. Non-
practitioners handling this substance must also comply with the
employee screening requirements of 21 CFR 1301.90-1301.93.
3. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of N-ethylpentylone must be in compliance with 21
U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers are permitted to
manufacture N-ethylpentylone in accordance with a quota assigned
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
5. Inventory. Any person registered with DEA to handle N-
ethylpentylone must have an initial inventory of all stocks of
controlled substances (including N-ethylpentylone) on hand on the date
the registrant first engages in the handling of the controlled
substances pursuant to 21 U.S.C. 827 and 958, 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 N-ethylpentylone) on hand every two years
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to N-ethylpentylone pursuant to 21
U.S.C. 827 and 958(e), and in accordance with 21 CFR 1301.74(b) and (c)
and parts 1304, 1312, and 1317.
7. Order Forms. Every DEA registrant who distributes N-
ethylpentylone must continue to comply with the order form
requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of
N-ethylpentylone must be in compliance with 21 U.S.C. 952, 953, 957,
and 958, and in accordance with 21 CFR part 1312.
9. Liability. Any activity involving N-ethylpentylone 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 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a), this final scheduling action
is subject to formal rulemaking procedures performed ``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.
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.
[[Page 31429]]
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 Acting Administrator, in accordance with the Regulatory
Flexibility Act (RFA), 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 entities. On August
31, 2018, DEA published an order to temporarily place N-ethylpentylone
in schedule I of the CSA pursuant to the temporary scheduling
provisions of 21 U.S.C. 811(h). On August 27, 2020, DEA published a
temporary scheduling order extending the temporary scheduling of N-
ethylpentylone for up to one year pursuant to 21 U.S.C. 811(h)(2).
Accordingly, all entities that currently handle or plan to handle N-
ethylpentylone have already been required to establish and implement
the systems and processes required to specifically handle N-
ethylpentylone. There are currently 31 unique registrations authorized
to handle N-ethylpentylone specifically, 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 and the majority of DEA registrants are small entities
or are employed by small entities, DEA estimates a maximum of 26
entities are small entities. Therefore, DEA conservatively estimates as
many as 26 small entities are affected by this rule.
A review of the 31 registrations indicates that all entities that
currently handle N-ethylpentylone also handle other schedule I
controlled substances, and thus they have established and implemented
(or maintain) the systems and processes required to handle N-
ethylpentylone as a schedule I substance. Therefore, DEA anticipates
that this 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 26 affected small entities. Therefore, DEA has
concluded that this rule will not have a significant economic impact on
a substantial number of small entities.
Unfunded Mandates Reform Act of 1995 (UMRA)
In accordance with 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 UMRA of 1995.
Determination To Make Rule Effective Immediately
As indicated above, this rule finalizes the schedule I control
status of N-ethylpentylone that has already been in effect since the
publication of an order in the Federal Register amending 21 CFR
1308.11(h) to temporarily place N-ethylpentylone in schedule I of the
CSA pursuant to the temporary scheduling provisions of 21 U.S.C.
811(h). 83 FR 44474. The August 2018 order was effective on the date of
publication, and was based on findings by the then-Acting Administrator
that the temporary scheduling of N-ethylpentylone 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 N-
ethylpentylone that has already been in effect for over two and half
years, it does not alter the legal obligations of any person who
handles this substance. Rather, it merely makes permanent the current
scheduling status and corresponding legal obligations. Therefore, 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.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information under
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action
would not impose recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or organizations. 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 (CRA)
This rule is not a major rule as defined by the CRA, 5 U.S.C. 804.
However, pursuant to the CRA, DEA is submitting a copy of this final
rule to both Houses of Congress and to the Comptroller General.
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 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. Add paragraph (d)(86); and
0
b. Remove and reserve paragraph (h)(36).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(86) N-ethylpentylone (Other names: ephylone, 1-(1,3-benzodioxol- 7543
5-yl)-2-(ethylamino)pentan-1-one)..............................
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-12261 Filed 6-11-21; 8:45 am]
BILLING CODE 4410-09-P
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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.