[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Pages 32996-32999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11740]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-495]


Schedules of Controlled Substances: Placement of N-
Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-Methyl-alpha-
ethylaminopentiophenone, 4'-Methyl-alpha-pyrrolidinohexiophenone, 
alpha-Pyrrolidinoheptaphenone, and 4'-Chloro-alpha-
pyrrolidinovalerophenone in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: By this rule, the Drug Enforcement Administration permanently 
places six synthetic cathinones, as identified in this rule, in 
schedule I of the Controlled Substances Act. These six substances are 
currently listed in schedule I pursuant to a temporary scheduling 
order. As a result of this rule, 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 these six specified controlled substances will continue to 
apply.

DATES: Effective June 1, 2022.

FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical 
Evaluation Section, Diversion Control Division, Drug Enforcement 
Administration; Telephone: (571) 362-8207.

SUPPLEMENTARY INFORMATION: In this rule, the Drug Enforcement 
Administration (DEA) is permanently

[[Page 32997]]

scheduling the following six controlled substances, including their 
optical, positional, and geometric isomers, salts, and salts of isomers 
whenever the existence of such salts, isomers, and salts of isomers is 
possible within the specific chemical designation, in schedule I of the 
Controlled Substances Act (CSA):
    <bullet> N-ethylhexedrone (other names: [alpha]-
ethylaminohexanophenone, 2-(ethylamino)-1-phenylhexan-1-one),
    <bullet> alpha-pyrrolidinohexanophenone (other names: [alpha]-PHP, 
[alpha]-pyrrolidinohexanophenone, 1-phenyl-2-(pyrrolidin-1-yl)hexan-1-
one),
    <bullet> 4-methyl-alpha-ethylaminopentiophenone (other names: 4-
MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one),
    <bullet> 4'-methyl-alpha-pyrrolidinohexiophenone (other names: 
MPHP, 4'-methyl-alpha-pyrrolidinohexanophenone, 1-(4-methylphenyl)-2-
(pyrrolidin-1-yl)hexan-1-one),
    <bullet> alpha-pyrrolidinoheptaphenone (other names: PV8, 1-phenyl-
2-(pyrrolidin-1-yl)heptan-1-one), and
    <bullet> 4'-chloro-alpha-pyrrolidinovalerophenone (other names: 4-
chloro-[alpha]-PVP, 4'-chloro-[alpha]-pyrrolidinopentiophenone, 1-(4-
chlorophenyl)-2-(pyrrolidin-1-yl)pentan-1-one).

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. 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 is supported by, inter alia, a recommendation 
from the Assistant Secretary for Health of HHS (Assistant Secretary) 
and an evaluation of all other relevant data by DEA. The regulatory 
controls and administrative, civil, and criminal sanctions for schedule 
I controlled substances on any person who handles or proposes to handle 
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-
PVP will continue to apply as a result of this action.
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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

    The subject substances of this final rule are currently controlled 
in schedule I of the CSA by virtue of a temporary scheduling order (84 
FR 34291, July 18, 2019) and an extension of that order (86 FR 37672, 
July 16, 2021). On July 16, 2021, pursuant to 21 U.S.C. 811(a), DEA 
published a notice of proposed rulemaking (NPRM) to permanently control 
these six synthetic cathinones in schedule I of the CSA. 86 FR 37719.

NPRM

    DEA's July 2021 rule proposed to permanently control N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP, and their optical, positional, and geometric isomers, salts, and 
salts of isomers in schedule I of the CSA. Specifically, DEA proposed 
to add these six synthetic cathinones to the hallucinogenic substances 
list under 21 CFR 1308.11(d)(94) through (99), respectively. The 
proposed regulatory text provided name(s) for these six substances as 
follows:
    <bullet> N-ethylhexedrone (other name: [alpha]-
ethylaminohexanophenone),
    <bullet> alpha-pyrrolidinohexanophenone (other names: [alpha]-PHP, 
[alpha]-pyrrolidino-hexanophenone, 1-phenyl-2-(pyrrolidin-1-yl)hexan-1-
one),
    <bullet> 4-methyl-alpha-ethylaminopentiophenone (other names: 4-
MEAP, 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one),
    <bullet> 4'-methyl-alpha-pyrrolidinohexiophenone (other names: 
MPHP, 4-methyl-alpha-pyrrolidino hexanophenone,, 1-(4-methylphenyl)-2-
(pyrrolidin-1-yl)hexan-1-one),
    <bullet> alpha-pyrrolidinoheptaphenone (other names: PV8, 1-phenyl-
2-(pyrrolidin-1-yl)heptan-1-one), and
    <bullet> 4'-chloro-alpha-pyrrolidinovalerophenone (other names: 4-
chloro-[alpha]-PVP, 4-chloro-[alpha]-pyrrolidinopentiophenone, 1-(4-
chlorophenyl)-2-(pyrrolidin-1-yl)pentan-1-one).
    Regarding the substance N-ethylhexedrone, the preamble 
(Supplementary Information section) for the NPRM provided [alpha]-
ethylaminohexanophenone as well as multiple other names, including 2-
(ethylamino)-1-phenylhexan-1-one.\2\
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    \2\ In addition to [alpha]-ethylaminohexanophenone and 2-
(ethylamino)-1-phenylhexan-1-one, the NPRM preamble provided two 
other names (ethyl hexedrone and HEXEN).
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    The NPRM provided an opportunity for interested persons to file a 
request for hearing in accordance with DEA regulations on or before 
August 16, 2021. 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 August 16, 2021. DEA did not 
receive any comments.

Determination for Permanent Scheduling

    Based on the rationale set forth in the NPRM, the Administrator 
makes the findings, required under 21 U.S.C. 811(a) and 812(b)(1), for 
permanent placement of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, 
PV8, and 4-chloro-[alpha]-PVP, including their salts, isomers, and 
salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation, 
in schedule I of the CSA. This final rule adds the six substances to 
the hallucinogenic substances list under 21 CFR 1308.11(d), and 
maintains their placement in schedule I. This final rule provides the 
same other names for all six specific substances, used in the 
regulatory text of the NPRM. In addition, this rule adds one other 
name, 2-(ethylamino)-1-phenylhexan-1-one, for the substance N-
ethylhexedrone. As discussed above, this additional other name was 
provided in the preamble for the NPRM.

Requirements for Handling N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, 
PV8, and 4-Chloro-[alpha]-PVP

    N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-
[alpha]-PVP 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, research, and conduct of instructional 
activities involving the handling of schedule I controlled substances 
including the following:
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    \3\ N-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP have been subject to schedule I controls on a 
temporary basis, pursuant to 21 U.S.C. 811(h), by virtue of the 
temporary scheduling order (84 FR 34291, July 18, 2019) and the 
subsequent one year extension of that order (86 FR 37672, July 16, 
2021).
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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) or 
who desires to handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, 
or 4-chloro-[alpha]-PVP must be registered with DEA to

[[Page 32998]]

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-Ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 
4-chloro-[alpha]-PVP 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 N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP 
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-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, 
PV8, and 4-chloro-[alpha]-PVP must be in compliance with 21 U.S.C. 825, 
and be in accordance with 21 CFR part 1302.
    4. Quota. Only registered manufacturers are permitted to 
manufacture N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-
chloro-[alpha]-PVP in accordance with a quota assigned pursuant to 21 
U.S.C. 826 and in accordance with 21 CFR part 1303.
    5. Inventory. Every DEA registrant who possesses any quantity of N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP 
was required to keep an inventory of all stocks of these substances on 
hand as of July 18, 2019, pursuant to 21 U.S.C. 827 and 958 and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d).
    6. Records and Reports. DEA registrants must maintain records and 
submit reports with respect to N-ethylhexedrone, [alpha]-PHP, 4-MEAP, 
MPHP, PV8, or 4-chloro-[alpha]-PVP 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. 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.
    7. Order Forms. Every DEA registrant who distributes N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP 
must continue to comply with the order form requirements, pursuant to 
21 U.S.C. 828 and in accordance with 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-
PVP must continue to 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-ethylhexedrone, [alpha]-PHP, 
4-MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP 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 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 final 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 final 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 final rule and by approving it 
certifies that it will not have a significant economic impact on a 
substantial number of small entities. On July 18, 2019, DEA published 
an order to temporarily place N-ethylhexedrone, [alpha]-PHP, 4-MEAP, 
MPHP, PV8, and 4-chloro-[alpha]-PVP in schedule I of the CSA pursuant 
to the temporary scheduling provisions of 21 U.S.C. 811(h). 84 FR 
34291. DEA estimates that all entities handling or planning to handle 
these substances have already established and implemented the systems 
and processes required to handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP, 
MPHP, PV8, or 4-chloro-[alpha]-PVP. There are currently 34 unique 
registrations authorized to handle N-ethylhexedrone, [alpha]-PHP, 4-
MEAP, MPHP, PV8, or 4-chloro-[alpha]-PVP specifically, as well as a 
number of registered analytical labs that are authorized to handle 
schedule I controlled substances generally. From review of entity 
names, DEA estimates these 34 registrations represent 29 entities. 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 29 entities are small entities. Therefore, DEA 
conservatively estimates as many as 29 small entities are affected by 
this proposed rule.
    A review of the 34 registrations indicates that all entities that 
currently handle N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, or 
4-chloro-[alpha]-PVP also handle other schedule I controlled 
substances, and thus they have established and implemented (or 
maintain) the systems and processes required to handle N-
ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-
PVP as a schedule I substance. 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 29 affected 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 $100,000,000 or more (adjusted annually 
for inflation) in any 1 year * * * .'' Therefore, neither a Small 
Government Agency Plan nor any

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other action is required under UMRA of 1995.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is 
submitting a copy of the final rule to both Houses of Congress and to 
the Comptroller General.

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.

Determination To Make Rule Effective Immediately

    As indicated above, this rule finalizes the schedule I control 
status of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-
chloro-[alpha]-PVP that has already been in effect for over two years 
by virtue of the temporary scheduling order (84 FR 34291, July 18, 
2019) and the subsequent one year extension of that order (86 FR 37672, 
July 16, 2021). The July 2019 order was effective on the date of 
publication, and was based on findings by the then-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).
    Because this rule finalizes the control status of N-ethylhexedrone, 
[alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP that has 
already been in effect for over two years, 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, 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. See 5 U.S.C. 553(d).

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 Sec.  1308.11, add paragraphs (d)(94) through (99) and remove and 
reserve paragraphs (h)(42) through (47).
    The additions read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

(94) N-Ethylhexedrone (Other names: [alpha]-                        7246
 ethylaminohexanophenone; 2-(ethylamino)-1-phenylhexan-1-
 one)...................................................
(95) alpha-Pyrrolidinohexanophenone (Other names:                   7544
 [alpha]-PHP; [alpha]-pyrrolidinohexanophenone; 1-phenyl-
 2-(pyrrolidin-1-yl)hexan-1-one)........................
(96) 4-Methyl-alpha-ethylaminopentiophenone (Other                  7245
 names: 4-MEAP; 2-(ethylamino)-1-(4-methylphenyl)pentan-
 1-one).................................................
(97) 4'-Methyl-alpha-pyrrolidinohexiophenone (Other                 7446
 names: MPHP; 4'-methyl-alpha-pyrrolidinohexanophenone;
 1-(4-methylphenyl)-2-(pyrrolidin-1-yl)hexan-1-one).....
(98) alpha-Pyrrolidinoheptaphenone (Other names: PV8; 1-            7548
 phenyl-2-(pyrrolidin-1-yl)heptan-1-one)................
(99) 4'-Chloro-alpha-pyrrolidinovalerophenone (Other                7443
 names: 4-chloro-[alpha]-PVP; 4'-chloro-[alpha]-
 pyrrolidinopentiophenone; 1-(4-chlorophenyl)-2-
 (pyrrolidin-1-yl)pentan-1-one).........................
 

* * * * *

Anne Milgram,
Administrator.
[FR Doc. 2022-11740 Filed 5-31-22; 8:45 am]
BILLING CODE 4410-09-P