[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 [www.gpo.gov]
[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 http://www.regulations.gov 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.

[[Page 33510]]

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