Rule2021-13460
Schedules of Controlled Substances: Placement of para-Methoxymethamphetamine (PMMA) 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
June 25, 2021
Effective
July 26, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration places 1-(4-methoxyphenyl)-N-methylpropan-2-amine (para- methoxymethamphetamine, PMMA), including its 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 Controlled Substances Act to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. 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, conduct instructional activities or chemical analysis, or possess), or propose to handle PMMA.
Full Text
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<title>Federal Register, Volume 86 Issue 120 (Friday, June 25, 2021)</title>
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[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Rules and Regulations]
[Pages 33508-33510]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13460]
[[Page 33508]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-509]
Schedules of Controlled Substances: Placement of para-
Methoxymethamphetamine (PMMA) 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 1-(4-methoxyphenyl)-N-methylpropan-2-amine (para-
methoxymethamphetamine, PMMA), including its 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 Controlled Substances Act to enable the United States
to meet its obligations under the 1971 Convention on Psychotropic
Substances. 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, conduct instructional activities or
chemical analysis, or possess), or propose to handle PMMA.
DATES: Effective July 26, 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 1971 United Nations Convention
on Psychotropic Substances (1971 Convention), February 21, 1971, 32
U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting
changes in drug schedules under the 1971 Convention are governed
domestically by 21 U.S.C. 811(d)(2)(4). When the United States receives
notification of a scheduling decision pursuant to Article 2 of the 1971
Convention adding a drug or other substance to a specific schedule, the
Secretary of the Department of Health and Human Services (HHS),\1\
after consultation with the Attorney General, shall determine whether
existing legal controls under subchapter I of the Controlled Substances
Act (CSA) and the Federal Food, Drug, and Cosmetic Act meet the
requirements of the schedule specified in the notification with respect
to the specific drug or substance. 21 U.S.C. 811(d)(3). In the event
that the Secretary of HHS did not so consult with the Attorney General,
and the Attorney General did not issue a temporary order, as provided
under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set
forth in 21 U.S.C. 811(a) and (b) control. Pursuant to 21 U.S.C.
811(a)(1), the Attorney General may, by rule, schedule or transfer
between schedules any drug or other substance, if he finds that such
drug or other substance has a potential for abuse, and makes the
findings prescribed by 21 U.S.C. 812(b) to schedule the drug or other
substance. The Attorney General has delegated this scheduling authority
to the Administrator of the Drug Enforcement Administration (DEA). 28
CFR 0.100.
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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, March 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
para-Methoxymethamphetamine (PMMA) is a substituted phenethylamine
and shares structural similarity to methamphetamine, a schedule II
controlled substance, and para-methoxyamphetamine (PMA), a schedule I
controlled substance. PMMA shares a similar pharmacological profile
with 3,4-methylenedioxymethamphetamine (MDMA or ecstasy), a schedule I
controlled substance with high potential for abuse. Data obtained from
preclinical studies show that, similar to MDMA, PMMA's effects are
mediated by monoaminergic (dopamine, norepinephrine, and serotonin)
transmission, mostly via activation of the serotonergic system. In
animals, PMMA mimics MDMA in producing discriminative stimulus effect,
which is indicative of similar subjective effects. Law enforcement has
encountered PMMA on the recreational drug market where it is sold as
``ecstasy,'' either alone or in combination with MDMA or PMA for oral
consumption. For many years, PMMA has been involved in non-fatal and
fatal overdoses, primarily in Europe. PMMA has no accepted medical use
in treatment in the United States. In March 2016, the Commission on
Narcotic Drugs (CND) voted to place PMMA in Schedule I of the 1971
Convention (CND Dec/59/3) during its 59th Session due to its dependence
and abuse potential.
DEA and HHS Eight Factor Analyses
On December 18, 2018, in accordance with 21 U.S.C. 811(b), and in
response to DEA's April 7, 2017 request, HHS provided to DEA a
scientific and medical evaluation and scheduling recommendation for
PMMA. DEA reviewed HHS' evaluation and recommendation for schedule I
placement, and all other relevant data, pursuant to 21 U.S.C. 811(b)
and (c), and conducted its own analysis under the eight factors
stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C. 812(b)(1),
that this substance warrants control in schedule I. Both DEA and HHS 8-
Factor analyses are available in their entirety under the tab
``Supporting Documents'' of the public docket for this action at <a href="http://www.regulations.gov">http://www.regulations.gov</a> under Docket Number ``DEA-509.''
Notice of Proposed Rulemaking to Schedule PMMA
On May 15, 2020 (85 FR 29359), DEA published a notice of proposed
rulemaking (NPRM) to permanently control PMMA in schedule I.
Specifically, DEA proposed to add PMMA to the hallucinogenic substances
list under 21 CFR 1308.11(d), and assign paragraph number 79 under
paragraph (d) to PMMA. The NPRM provided an opportunity for interested
persons to file a request for hearing in accordance with DEA
regulations on or before June 15, 2020. No requests for such a hearing
were received by DEA. The NPRM also provided an opportunity for
interested persons to submit comments on or before June 15, 2020. DEA
did not receive any comments.
Scheduling Conclusion
After consideration of 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 PMMA. DEA
is permanently scheduling PMMA 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 specifies the findings
required to
[[Page 33509]]
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 for Health of HHS and review of all other available
data, the Acting Administrator of DEA (Acting Administrator), pursuant
to 21 U.S.C. 811(a) and 812(b)(1), finds that:
(1) The Drug or Substance Has a High Potential for Abuse
PMMA has a mechanism of action similar to that of MDMA, a schedule
I controlled substance. Similar to MDMA, PMMA increases levels of
monoamines, specifically DA and 5-HT, in the brain reward circuitry.
Data from animal studies demonstrate that PMMA fully substitutes for
the discriminative stimulus effect of MDMA, which is indicative of
similar subjective effects. Although there is currently no data that
has directly assessed the psychological or physiological dependence
liability of PMMA, its pharmacological similarities to MDMA suggest it
likely has low physical dependence liability. Evidence demonstrates
that users of PMMA are often seeking MDMA, which may be mixed with
PMMA. PMMA shares a pharmacological mechanism of action and
psychoactive effects similar to the schedule I controlled substance
MDMA and therefore has a high potential for abuse.
(2) The Drug or Substance Has No Currently Accepted Medical Use in
Treatment in the United States
According to HHS, the Food and Drug Administration (FDA) has not
approved any marketing application for a drug product containing PMMA
for any indication. In addition, there are no clinical studies or
petitioners that have claimed an accepted medical use of PMMA in the
United States. Thus, PMMA has no currently accepted medical use in
treatment in the United States.\2\
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\2\ Although there is no evidence suggesting that PMMA has a
currently accepted medical uses 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 the Drug or Substance
Under Medical Supervision
The safety of PMMA for use under medical supervision has not been
determined because it has no approved medical use in treatment in the
United States and has not been investigated as a new drug. Therefore,
there is a lack of accepted safety for use of PMMA under medical
supervision.
Based on these findings, the Acting Administrator concludes that
PMMA as well as its salts, isomers, and salts of isomers whenever the
existence of such isomers and salts is possible within the specific
chemical designation warrants control in schedule I of the CSA. 21
U.S.C. 812(b)(1).
Summary of Minor Change in the Final Rule
As discussed in the above NPRM section, DEA proposed to place PMMA
in 21 CFR 1301.11(d) as paragraph number 79. Since the publication of
this NPRM, DEA has issued several final rules which updated the
numbering of listed hallucinogenic substances in paragraph (d). As a
result, this final rule assigns paragraph number 88 to PMMA.
Requirements for Handling PMMA
PMMA is subject to the CSA's schedule I regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, reverse distribution, import, export,
engagement in research, conduct of instructional activities or chemical
analysis with, and possession of schedule I controlled substances,
including the following:
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, PMMA must be registered with DEA to conduct such
activities 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 PMMA must surrender
all quantities of currently held PMMA, or transfer all quantities of
currently held PMMA to a person registered with DEA. PMMA 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. PMMA is 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 PMMA
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 PMMA must comply with 21 U.S.C. 825, and be in
accordance with 21 CFR part 1302.
5. Quota. Only registered manufacturers are permitted to
manufacture PMMA 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
PMMA must take an inventory of PMMA on hand pursuant to 21 U.S.C. 827,
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d).
Any person who becomes registered with DEA must take an initial
inventory of all stocks of controlled substances (including PMMA) on
hand on the date the registrant first engages in the handling of
controlled substances, pursuant to 21 U.S.C. 827,and in accordance with
21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including PMMA) on hand every
two years, pursuant to 21 U.S.C. 827, 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 for PMMA, or products containing PMMA, pursuant to
21 U.S.C. 827, and in accordance with 21 CFR 1301.74(b) and (c) and
parts 1304, 1312, and 1317. Manufacturers and distributors must submit
reports regarding PMMA 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 PMMA must
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
PMMA must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and
in accordance with 21 CFR part 1312.
10. Liability. Any activity involving PMMA 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.
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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 procedures
and 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.
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, 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.
DEA is placing the substance PMMA (chemical name 1-(4-
methoxyphenyl)-N-methylpropan-2-amine), including its 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 to enable the United States to meet its
obligations under the 1971 Convention. This action imposes 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 with,
or possess) or propose to handle PMMA.
Based on the review of HHS' scientific and medical evaluation and
all other relevant data, DEA determined that PMMA has a high potential
for abuse, has no currently accepted medical use in treatment in the
United States, and lacks accepted safety for use under medical
supervision. DEA's research confirms that there is no legitimate
commercial market for PMMA in the United States. Therefore, DEA
estimates that no United States entity currently handles PMMA and does
not expect any United States entity to handle PMMA in the foreseeable
future. DEA concludes that no legitimate United States entity would be
affected by this rule. As such, this rule will not have a significant
effect 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 other action is required under UMRA of
1995.
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
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 this final rule 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, 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. Amend Sec. 1308.11 by adding paragraph (d)(88) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(88) 1-(4-methoxyphenyl)-N-methylpropan-2-amine (other names: (1245)
para-methoxymethamphetamine, PMMA)............................
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-13460 Filed 6-24-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on June 25, 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.