Rule2021-23848
Schedules of Controlled Substances: Placement of Isotonitazene in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 4, 2021
Effective
December 6, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing N,N-diethyl- 2-(2-(4-isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine (commonly known as isotonitazene), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States' obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose 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 isotonitazene.
Full Text
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<title>Federal Register, Volume 86 Issue 211 (Thursday, November 4, 2021)</title>
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[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Rules and Regulations]
[Pages 60761-60763]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23848]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-631]
Schedules of Controlled Substances: Placement of Isotonitazene in
Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final amendment; final order.
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SUMMARY: With the issuance of this final order, the Administrator of
the Drug Enforcement Administration is permanently placing N,N-diethyl-
2-(2-(4-isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine
(commonly known as
isotonitazene), including its isomers, esters, ethers, salts, and
salts of isomers, esters, and ethers whenever the existence of such
isomers, esters, ethers, and salts is possible within the specific
chemical designation, in schedule I of the Controlled Substances Act.
This scheduling action discharges the United States' obligations under
the Single Convention on Narcotic Drugs (1961). This action continues
to impose 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 isotonitazene.
DATES: Effective December 6, 2021.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
Legal Authority
The United States is a party to the 1961 United Nations Single
Convention on Narcotic Drugs (Single Convention), March 30, 1961, 18
U.S.T. 1407, 570 U.N.T.S. 151, as amended by the 1972 Protocol. Article
3, paragraph 7 of the Single Convention requires that if the Commission
on Narcotic Drugs (Commission) adds a substance to one of the schedules
of such Convention, and the United States receives notification of such
scheduling decision from the Secretary-General of the United Nations
(Secretary-General), the United States, as a signatory Member State, is
obligated to control the substance under its national drug control
legislation. Under 21 U.S.C. 811(d)(1)), 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 must 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 21 U.S.C. 811(a) or 812(b), and without regard
to the procedures prescribed by 21 U.S.C. 811(a) and (b). The Attorney
General has delegated scheduling authority under 21 U.S.C. 811 to the
Administrator of the Drug Enforcement Administration (Administrator of
DEA or Administrator). 28 CFR 0.100.
Background
On August 20, 2020, DEA issued a temporary scheduling order,
placing isotonitazene (N,N-diethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-
1H-benzimidazol-1-yl)ethan-1-amine), in schedule I of the Controlled
Substances Act (CSA). 85 FR 51342. That order was based on findings by
the Acting Administrator of DEA (Acting Administrator) that the
temporary scheduling of this substance was necessary to avoid an
imminent hazard to the public safety; the order was codified at 21 CFR
1308.11(h)(48).
In November 2020, the Director-General of the World Health
Organization recommended to the Secretary-General that isotonitazene be
placed in Schedule I of the Single Convention, as this substance has an
opioid mechanism of action and similarity to drugs that are controlled
in Schedule I of the Single Convention (i.e., isotonitazene is similar
to drugs such as morphine and fentanyl), and has dependence and abuse
potential. On June 10, 2021, the Secretary-General advised the
Secretary of State of the United States, by letter, that during its
64th session in April 2021, the Commission voted to place isotonitazene
in Schedule I of the Single Convention (CND Apr/64/1).
Isotonitazene
As discussed in the background section, isotonitazene is
temporarily controlled in schedule I of the CSA upon the Acting
Administrator's finding it poses imminent hazard to the public safety.
Isotonitazene has a pharmacological profile similar to etonitazene
(schedule I), fentanyl (schedule II), and other schedule I and II
synthetic opioids that act as mu-opioid receptor agonists. Because of
the pharmacological similarities of isotonitazene to etonitazene (a
potent mu-opioid agonist), the use of isotonitazene presents a high
risk of abuse and has negatively affected users and communities. The
abuse of isotonitazene has been associated with
[[Page 60762]]
at least 48 <SUP>1 2</SUP> fatalities in the United States between
August 2019 and July 2020. The positive identification of this
substance in post-mortem cases is a serious concern to the public
safety.
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\1\ Shover CL, Falasinnu TO, Freedman RB, Humphreys K. Emerging
Characteristics of Isotonitazene-Involved Overdose Deaths: A Case-
Control Study. J Addict Med. 2020 Nov 23:10.1097/
ADM.0000000000000775.
\2\ Krotulski AJ, Papsun DM, Kacinko SL, Logan BK. Isotonitazene
Quantitation and Metabolite Discovery in Authentic Forensic
Casework. J Anal Toxicol. 2020 Jul 31;44(6):521-530.
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Isotonitazene in the illicit drug market has been reported in
Canada, Estonia, Germany, Latvia, Sweden, and the United States since
April 2019.\3\ Law enforcement reports demonstrate that isotonitazene
is being illicitly distributed and abused. The illicit use and
distribution of this substance are similar to that of heroin (schedule
I) and prescription opioid analgesics. According to the National
Forensic Laboratory Information System (NFLIS-Drug) database, which
collects drug identification results from drug cases submitted to and
analyzed by Federal, State and local forensic laboratories, there have
been 181 reports for isotonitazene between January 2019 and December
2020 \4\ (query date: May 28, 2021).
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\3\ European Monitoring Centre for Drugs and Drug Addiction and
Europol. (2020). EMCDDA initial report on the new psychoactive
substance N,N-diethyl-2-[[4-(1 methylethoxy)phenyl]methyl]-5-nitro-
1H-benzimidazole-1-ethanamine (isotonitazene). In accordance with
Article 5b of Regulation (EC) No 1920/2006 (as amended),
Publications Office of the European Union, Luxembourg.
\4\ Reports to NFLIS-Drug are still pending for 2020.
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DEA is not aware of any claims or any medical or scientific
literature suggesting that isotonitazene has a currently accepted
medical use in treatment in the United States. In addition, the
Department of Health and Human Services advised DEA, by letter dated
March 31, 2020, that there were no investigational new drug
applications or approved new drug applications for isotonitazene in the
United States. Because isotonitazene is not formulated or available for
clinical use as an approved medicinal product, all current use of this
substance by individuals is based on their own initiative, rather than
on the basis of medical advice from a practitioner licensed by law to
administer such a drug.
Therefore, consistent with 21 U.S.C. 811(d)(1), DEA concludes that
isotonitazene has no currently accepted medical use in treatment in the
United States \5\ and is most appropriately placed in schedule I of the
CSA, the same schedule in which it currently resides. Because control
is required under the Single Convention, DEA will not be initiating
regular rulemaking proceedings to schedule isotonitazene pursuant to 21
U.S.C. 811(a).
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\5\ Although, as discussed above, there is no evidence
suggesting that isotonitazene 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 the Food and Drug Administration, 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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Conclusion
In order to meet the United States' obligations under the Single
Convention and because isotonitazene has no currently accepted medical
use in treatment in the United States, the Administrator has determined
that isotonitazene, including its isomers, esters, ethers, salts, and
salts of isomers, esters, and ethers, whenever the existence of such
isomers, esters, ethers, and salts is possible within the specific
chemical designation, should remain in schedule I of the CSA.
Requirements for Handling
Isotonitazene has been controlled as a schedule I controlled
substance since August 20, 2020. Upon the effective date of the final
order contained in this document, isotonitazene will be permanently
subject to the CSA's schedule I regulatory controls and administrative,
civil, and criminal sanctions applicable to the manufacture of,
distribution of, importation of, exportation of, engagement in research
or conduct of instructional activities with, 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, isotonitazene
must be registered with DEA to conduct such activities pursuant to 21
U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301
and 1312. Retail sales of schedule I controlled substances to the
general public are not allowed under the CSA. Possession of any
quantity of these substances in a manner not authorized by the CSA is
unlawful and those in possession of any quantity of these substances
may be subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Isotonitazene 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. Isotonitazene is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 821
and 823, and in accordance with 21 CFR 1301.71-1301.76. Non-
practitioners handling isotonitazene must also comply with the employee
screening requirements of 21 CFR 1301.90-1301.93.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of isotonitazene must be in compliance with 21
U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.
5. Quota. Only registered manufacturers are permitted to
manufacture isotonitazene in accordance with a quota assigned pursuant
to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
6. Inventory. Every DEA registrant who possesses any quantity of
isotonitazene has been required to keep an inventory of all stocks of
this substance on hand as of August 20, 2020, 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. DEA registrants must maintain records and
submit reports with respect to isotonitazene pursuant to 21 U.S.C. 827
and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317,
and Sec. 1307.11. Manufacturers and distributors must submit reports
regarding isotonitazene 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. All DEA registrants who distribute isotonitazene
must continue to comply with 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
isotonitazene must continue to be in compliance with 21 U.S.C. 952,
953, 957, and 958, and in accordance with 21 CFR parts 1304, 1312, and
1317.
10. Liability. Any activity involving isotonitazene not authorized
by, or in violation of the CSA, is unlawful, and may subject the person
to administrative, civil, and/or criminal sanctions.
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Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and 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).
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 action does not have federalism implications warranting the
application of E.O. 13132. This action does not have substantial direct
effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This action does not have tribal implications warranting the
application of E.O. 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, as delegated to the Administrator, 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. Id.
In accordance with 21 U.S.C. 811(d)(1), scheduling actions for
drugs that are required to be controlled by the United States'
obligations under international treaties, conventions, or protocols in
effect on October 27, 1970, shall be issued by order (as compared to
scheduling by rule pursuant to 21 U.S.C. 811(a)). Therefore, 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 5
U.S.C. 553(a)(1) as an action involving a foreign affairs function of
the United States because it is being done pursuant to 21 U.S.C.
811(d)(1), which requires that the United States comply with its
obligations under the specified international agreements.
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
requirement 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.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies that this
action would not result in any Federal mandate that may result ``in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year * * *.'' Therefore, neither a Small
Government Agency Plan nor any other action is required under UMRA of
1995.
Congressional Review Act
This order is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, DEA is submitting the required
reports to the Government Accountability Office, the House, and the
Senate under the CRA.
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:
0
a. Redesignate paragraphs (b)(46) through (90) as paragraphs (b)(47)
through (91);
0
b. Add new paragraph (b)(46); and
0
c. Remove and reserve paragraph (h)(48).
The addition reads as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
(46) Isotonitazene (N,N-diethyl-2-(2-(4-isopropoxybenzyl)-5- 9614
nitro-1H-benzimidazol-1-yl)ethan-1-amine)......................
* * * * *
Anne Milgram,
Administrator.
[FR Doc. 2021-23848 Filed 11-3-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on November 4, 2021.
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.