[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Rules and Regulations]
[Pages 58557-58559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26853]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-451]


Schedules of Controlled Substances: Placement of MT-45 Into 
Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: With the issuance of this final order, the Administrator of 
the Drug Enforcement Administration places the substance MT-45 
(Systematic IUPAC Name: 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), 
including its salts, isomers, and salts of isomers into schedule I of 
the Controlled Substances Act. This scheduling action is pursuant to 
the Controlled Substances Act and is required in order for the United 
States to discharge its obligations under the Single Convention on 
Narcotic Drugs, 1961. This action imposes 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 or conduct instructional activities 
with, or possess), or propose to handle, MT-45.

DATES: Effective January 12, 2018.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

    Section 201(d)(1) of the Controlled Substances Act (CSA) (21 U.S.C. 
811(d)(1)) states that, if control of a substance is required ``by 
United States obligations under international treaties, conventions, or 
protocols in effect on October 27, 1970, the Attorney General shall 
issue an order controlling such drug under the schedule he deems most 
appropriate to carry out such obligations, without regard to the 
findings required by subsection (a) of this section [811(a)] or section 
812(b) . . . and without regard to the procedures prescribed by 
subsections (a) and (b) of this section [21 U.S.C. 811(a) and (b)] . . 
. .'' If a substance is added to one of the schedules of the Single 
Convention on Narcotic Drugs, 1961 (``Single Convention''), then, in 
accordance with article 3, paragraph 7 of the Convention, as a 
signatory Member State, the United States is obligated to control the 
substance under its national drug control legislation, the CSA. The 
Attorney General has delegated scheduling authority under 21 U.S.C. 811 
to the Administrator of the DEA. 28 CFR 0.100.

Background

    On May 17, 2016, the Secretary-General of the United Nations 
advised the Secretary of State of the United States, by letter, that 
during the 59th session of the Commission on Narcotic Drugs, MT-45 was 
added to schedule I of the Single Convention. This letter was prompted 
by a decision at the 59th session of the Commission on Narcotic Drugs 
in March 2016 to schedule MT-45 under schedule I of the Single 
Convention. As a signatory Member State to the Single Convention, the 
United States is obligated to control MT-45 under its national drug 
control legislation, the CSA, in the schedule deemed most appropriate 
to carry out its international obligations. 21 U.S.C. 811(d)(1).

MT-45

    MT-45 is an opioid analgesic drug with pharmacological effects 
similar to morphine. MT-45 was demonstrated to produce physical 
dependence in mice. This compound is a piperazine derivative and is 
structurally unrelated to most other opioids. There are two enantiomers 
of MT-45 (R and S). Both enantiomers bind to opioid receptors, however 
(S)-(+)-MT-45 binds with a greater affinity than that of (R)-(-)-MT-45. 
In functional studies, (S)-(+)-MT-45 has an analgesic effect similar to 
morphine. In comparison, the analgesic effect of (R)-(-)-MT-45 is low.
    Starting in 2013, MT-45 began appearing on the internet for sale as 
a `legal' opioid. Recent reports from Japan have indicated that MT-45 
is present in herbal and chemical mixtures containing synthetic 
cannabinoids and/or synthetic cathinones. Deaths associated with MT-45 
abuse have occurred in the United States and in Europe. In addition, 
there have been at least 13 non-fatal overdoses associated with abuse 
of MT-45. There are no published studies as to the safety of MT-45 for 
human use. The DEA is not aware of any claims or any medical or 
scientific literature suggesting that MT-45 has a currently accepted 
medical use in treatment in the United States. Accordingly, the DEA has 
not requested that the Department of Health and Human Services (HHS) 
conduct a scientific and medical evaluation of the substance's medical 
utility. Furthermore, the DEA is not required under 21 U.S.C. 811(d)(1) 
to make any findings required by 21 U.S.C. 811(a) or 812(b), and is not 
required to follow the procedures prescribed by 21 U.S.C. 811(a) and 
(b). Therefore, consistent with the framework of 21 U.S.C. 811(d), the 
DEA concludes that MT-45 has no currently accepted medical use in 
treatment in the United States and is most appropriately placed in 
schedule I of the CSA.

Conclusion

    In order to meet the obligations of the United States under the 
Single Convention on Narcotic Drugs, 1961, and because MT-45 has no 
currently accepted medical use in treatment in the United States, the 
Administrator of the Drug Enforcement Administration has determined 
that this substance should be placed in schedule I of the Controlled 
Substances Act.

Requirements for Handling

    Upon the effective date of this final order, MT-45 will become 
subject to the regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, 
importation, exportation, engagement in research, and conduct of 
instructional

[[Page 58558]]

activities, and possession of schedule I controlled substances 
including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research or conducts instructional 
activities with, or possesses), or who desires to handle, MT-45 must be 
registered with the 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, as of January 12, 2018. Any person who currently handles MT-
45, and is not registered with the DEA, must submit an application for 
registration and may not continue to handle MT-45 as of January 12, 
2018, unless the DEA has approved that application for registration 
pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR 
parts 1301 and 1312.
    2. Disposal of stocks. Any person who does not desire or is not 
able to obtain a schedule I registration to handle MT-45 must surrender 
all quantities of currently held MT-45, or may transfer all quantities 
of currently held MT-45 to a person registered with the DEA on or 
before January 12, 2018 in accordance with all applicable federal, 
state, local, and tribal laws. As of January 12, 2018, MT-45 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. MT-45 will be 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 1301.71-1301.93, as of 
January 12, 2018.
    4. Labeling and packaging. As of January 12, 2018, all labels, 
labeling, and packaging for commercial containers of MT-45 must be in 
compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR 
part 1302.
    5. Inventory. Every DEA registrant who possesses any quantity of 
MT-45 on the effective date of this order must take an inventory of all 
stocks of this substance on hand, 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 an inventory of all 
MT-45 on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, 
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records. All DEA registrants must maintain records with respect 
to MT-45 pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 
CFR parts 1304, and 1312, and 1317 as of January 12, 2018.
    7. Reports. All DEA registrants who manufacture or distribute MT-45 
must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 
CFR parts 1304 and 1312 as of January 12, 2018.
    8. Order Forms. All DEA registrants who distribute MT-45 must 
comply with order form requirements pursuant to 21 U.S.C. 828 and in 
accordance with 21 CFR part 1305 as of January 12, 2018.
    9. Importation and Exportation. All importation and exportation of 
MT-45 must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in 
accordance with 21 CFR part 1312 as of January 12, 2018.
    10. Quota. Only DEA registered manufacturers may manufacture MT-45 
in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in 
accordance with 21 CFR part 1303 as of January 12, 2018.
    11. Liability. Any activity involving MT-45 not authorized by, or 
in violation of the CSA, occurring as of January 12, 2018, is unlawful, 
and may subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Analyses

Executive Order 12866, Regulatory Planning and Review

    This action is not a significant regulatory action as defined by 
Executive Order 12866 (Regulatory Planning and Review), section 3(f), 
and, accordingly, this action has not been reviewed by the Office of 
Management and Budget (OMB).

Executive Order 13132, Federalism

    This action does not have federalism implications warranting the 
application of Executive Order 13132. The action 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

    This action does not have tribal implications warranting the 
application of Executive Order 13175. The action 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.

Administrative Procedure Act

    The CSA provides for an expedited scheduling action where control 
is required by the United States obligations under international 
treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is 
required pursuant to such international treaty, convention, or 
protocol, the Attorney General must issue an order controlling such 
drug under the schedule he deems most appropriate to carry out such 
obligations, without regard to the findings or procedures otherwise 
required for scheduling actions.
    To the extent that 21 U.S.C. 811(d)(1) directs that if control is 
required by the United States obligations under international treaties, 
conventions, or protocols in effect on October 27, 1970, scheduling 
actions shall be issued by order (as compared to scheduling pursuant to 
21 U.S.C. 811(a) by rule), the DEA believes that the notice and comment 
requirements of section 553 of the Administrative Procedure Act (APA), 
5 U.S.C. 553, do not apply to this scheduling action. In the 
alternative, even if this action does constitute ``rule making'' under 
5 U.S.C. 551(5), this action is exempt from the notice and comment 
requirements of 5 U.S.C. 553 pursuant to 21 U.S.C. 553(a)(1) as an 
action involving a foreign affairs function of the United States given 
that this action is being done in accordance with 21 U.S.C. 811(d)(1)'s 
requirement that such action be taken to comply with the United States 
obligations under the specified international agreement.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA or any other law. As explained above, the CSA exempts this 
final order from notice and comment. Consequently, the RFA does not 
apply to this action.

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. 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 action is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). This order will not result in: ``an 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices for consumers, individual industries, Federal, 
State, or local government agencies, or geographic regions; or 
significant adverse effects on

[[Page 58559]]

competition, employment, investment, productivity, innovation, or on 
the ability of United States-based enterprises to compete with foreign 
based enterprises in domestic and export markets.'' However, pursuant 
to the CRA, the DEA has submitted a copy of this order 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. Amend Sec.  1308.11 by:
0
a. Redesignating paragraphs (b)(40) through (57) as (b)(41) through 
(58);
0
b. Adding new paragraph (b)(40).
    The addition reads as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *
    (40) MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine) . . . 
(9560)
* * * * *

    Dated: December 5, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-26853 Filed 12-12-17; 8:45 am]
BILLING CODE 4410-09-P