33508 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules and Regulations 

1As 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. 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–509] 

Schedules of Controlled Substances: 

Placement of paraMethoxymethamphetamine (PMMA) in 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Drug Enforcement 

Administration places 1-(4- 

methoxyphenyl)-N-methylpropan-2- 

amine (paramethoxymethamphetamine, 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. 

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 nonfatal 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 


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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules and Regulations 33509 

2Although 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 wellcontrolled 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). 

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

(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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33510 Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules and Regulations 

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)-Nmethylpropan-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 

■ 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. 

■ 2. Amend § 1308.11 by adding 

paragraph (d)(88) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(88) 1-(4-methoxyphenyl)-N-methylpropan-2-amine (other names: para-methoxymethamphetamine, PMMA) .................................. (1245) 

* * * * * 

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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