This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

31427 

Vol. 86, No. 112 

Monday, June 14, 2021 

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, Mar. 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–482] 

Schedules of Controlled Substances: 

Placement of N-Ethylpentylone in 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration places 1-(1,3- 

benzodioxol-5-yl)-2- 

(ethylamino)pentan-1-one (known as Nethylpentylone or ephylone) and its 

optical, positional, and geometric 

isomers, salts, and salts of isomers 

whenever the existence of such salts, 

isomers, and salts of isomers is possible, 

in schedule I of the Controlled 

Substances Act. This action makes 

permanent the current imposition of 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, or possess), or propose to 

handle N-ethylpentylone. 

DATES: Effective date: June 14, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

8207. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The Controlled Substances Act (CSA) 

provides that proceedings for the 

issuance, amendment, or repeal of the 

scheduling of any drug or other 

substance may be initiated by the 

Attorney General (1) on his own motion; 

(2) at the request of the Secretary of the 

Department of Health and Human 

Services (HHS); 1 or (3) on the petition 

of any interested party. 21 U.S.C. 811(a). 

This action was initiated on the 

Attorney General’s own motion, as 

delegated to the Administrator of the 

Drug Enforcement Administration 

(DEA), and it is supported by a 

recommendation from the Assistant 

Secretary for Health of HHS (Assistant 

Secretary) and an evaluation of all other 

relevant data by DEA. This action makes 

permanent the current, temporary 

imposition of regulatory controls and 

administrative, civil, and criminal 

sanctions for schedule I controlled 

substances on any person who handles 

or proposes to handle N-ethylpentylone. 

Background 

On August 31, 2018, DEA published 

an order in the Federal Register 

amending 21 CFR 1308.11(h) to 

temporarily place 1-(1,3-benzodioxol-5- 

yl)-2-(ethylamino)pentan-1-one (known 

as N-ethylpentylone or ephylone) in 

schedule I of the CSA pursuant to the 

temporary scheduling provisions of 21 

U.S.C. 811(h). 83 FR 44474. That 

temporary scheduling order was 

effective on the date of publication, and 

was based on findings by the Acting 

Administrator of DEA that the 

temporary scheduling of this synthetic 

cathinone was necessary to avoid an 

imminent hazard to the public safety 

pursuant to section 811(h)(1). On 

August 27, 2020, DEA published an 

order to extend the temporary 

scheduling of N-ethylpentylone by one 

year, or until August 31, 2021, pursuant 

to section 811(h)(2). 85 FR 52915. Also, 

on that same date and in the same issue 

of the Federal Register, DEA 

simultaneously published a notice of 

proposed rulemaking (NPRM) to 

permanently control N-ethylpentylone 

in schedule I of the CSA. 85 FR 52935. 

Specifically, DEA proposed to add Nethylpentylone to the hallucinogenic 

substances list under 21 CFR 

1308.11(d). 

DEA and HHS Eight Factor Analyses 

On July 15, 2020, HHS provided DEA 

with a scientific and medical evaluation 

document prepared by the Food and 

Drug Administration (FDA) entitled 

‘‘Basis for the Recommendation to 

Control N-ethylpentylone and Its 

Optical, Geometric, and Positional 

Isomers, Salts, and Salts of Isomers in 

Schedule I of the Controlled Substances 

Act.’’ After considering the eight factors 

in 21 U.S.C. 811(c) pursuant to 21 

U.S.C. 811(b), and N-ethylpentylone’s 

abuse potential, lack of legitimate 

medical use in the United States, and 

lack of accepted safety for use under 

medical supervision pursuant to 21 

U.S.C. 812(b), the Assistant Secretary 

recommended that N-ethylpentylone be 

controlled in schedule I of the CSA. 

In response, DEA conducted its own 

eightfactor analysis of N-ethylpentylone 

under 21 U.S.C. 811(c), and concluded 

that this substance warrants control in 

schedule I of the CSA, as it meets the 

findings prescribed by 21 U.S.C. 

812(b)(1). Both DEA and HHS eightfactor analyses are available in their 

entirety in the public docket for this 

rule (Docket Number DEA–482) at 

http://www.regulations.gov under 

‘‘Supporting Documents.’’ 

Determination to Schedule 

N-Ethylpentylone 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendation from HHS, DEA 

published an NPRM entitled ‘‘Schedules 

of Controlled Substances: Placement of 

N-ethylpentylone in Schedule I.’’ This 

rule proposed to control Nethylpentylone, and its optical, 

positional, and geometric isomers, salts, 

and salts of isomers in schedule I of the 

CSA. 85 FR 52935, August 27, 2020. The 

NPRM provided an opportunity for 

interested persons to file a request for 

hearing in accordance with DEA 

regulations on or before September 28, 

2020. No requests for such a hearing 

were received by DEA. The NPRM also 

provided an opportunity for interested 

persons to submit comments on the 

proposed rule on or before September 

28, 2020. 

Comment Received 

DEA received one anonymous 

comment on the proposed rule to 

control N-ethylpentylone in schedule I 


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31428 Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules and Regulations 

2Although there is no evidence suggesting that Nethylpentylone 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 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). 

3N-Ethylpentylone has been subject to schedule 

I controls on a temporary basis, pursuant to 21 

U.S.C. 811(h), by virtue of the August 31, 2018 

temporary scheduling order (83 FR 44474) and the 

subsequent one-year extension of that order (August 

27, 2020, 85 FR 52915). 

of the CSA. However, this comment was 

not related to the rule; therefore, DEA 

does not respond to the comment. 

Scheduling Conclusion 

After consideration of the relevant 

matter presented through the scientific 

and medical evaluation and the 

accompanying scheduling 

recommendation of HHS, and after its 

own eight-factor evaluation, DEA finds 

that these facts and all other relevant 

data constitute substantial evidence of 

potential for abuse of N-ethylpentylone. 

Accordingly, DEA is permanently 

scheduling N-ethylpentylone 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 outlines the findings required to 

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 and review of all other 

available data, the Acting 

Administrator, pursuant to 21 U.S.C. 

811(a) and 812(b)(1), finds that: 

(1) N-Ethylpentylone has a high 

potential for abuse; 

(2) N-Ethylpentylone has no currently 

accepted medical use in treatment in the 

United States; 2 and 

(3) There is a lack of accepted safety 

for use of N-ethylpentylone under 

medical supervision. 

Based on these findings, the Acting 

Administrator concludes that 1-(1,3- 

benzodioxol-5-yl)-2- 

(ethylamino)pentan-1-one (known as Nethylpentylone or ephylone) and its 

optical, positional, and geometric 

isomers, including its salts, isomers, and 

salts of isomers, whenever the existence 

of such salts, isomers, and salts of 

isomers is possible, warrants continued 

control in schedule I of the CSA. 21 

U.S.C. 812(b)(1). 

Requirements for Handling 

N-Ethylpentylone 

N-Ethylpentylone will continue 3 to 

be subject to the CSA’s schedule I 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, reverse 

distribution, importation, exportation, 

engagement in research, and 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) Nethylpentylone, or who desires to 

handle N-ethylpentylone, 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. 

2. Security. N-Ethylpentylone is 

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 

1301.71–1301.76. Non-practitioners 

handling this substance must also 

comply with the employee screening 

requirements of 21 CFR 1301.90– 

1301.93. 

3. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of N-ethylpentylone must be 

in compliance with 21 U.S.C. 825 and 

958(e), and be in accordance with 21 

CFR part 1302. 

4. Quota. Only registered 

manufacturers are permitted to 

manufacture N-ethylpentylone in 

accordance with a quota assigned 

pursuant to 21 U.S.C. 826 and in 

accordance with 21 CFR part 1303. 

5. Inventory. Any person registered 

with DEA to handle N-ethylpentylone 

must have an initial inventory of all 

stocks of controlled substances 

(including N-ethylpentylone) on hand 

on the date the registrant first engages 

in the handling of the controlled 

substances 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 a new inventory of all stocks 

of controlled substances (including Nethylpentylone) on hand every two 

years pursuant to 21 U.S.C. 827 and 958, 

and in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

6. Records and Reports. Every DEA 

registrant must maintain records and 

submit reports with respect to Nethylpentylone pursuant to 21 U.S.C. 

827 and 958(e), and in accordance with 

21 CFR 1301.74(b) and (c) and parts 

1304, 1312, and 1317. 

7. Order Forms. Every DEA registrant 

who distributes N-ethylpentylone must 

continue to comply with the order form 

requirements, pursuant to 21 U.S.C. 828 

and 21 CFR part 1305. 

8. Importation and Exportation. All 

importation and exportation of Nethylpentylone must be in compliance 

with 21 U.S.C. 952, 953, 957, and 958, 

and in accordance with 21 CFR part 

1312. 

9. Liability. Any activity involving Nethylpentylone 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. 

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 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. 


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Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules and Regulations 31429 

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 (RFA), 5 U.S.C. 601–602, 

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. 

On August 31, 2018, DEA published an 

order to temporarily place Nethylpentylone in schedule I of the CSA 

pursuant to the temporary scheduling 

provisions of 21 U.S.C. 811(h). On 

August 27, 2020, DEA published a 

temporary scheduling order extending 

the temporary scheduling of Nethylpentylone for up to one year 

pursuant to 21 U.S.C. 811(h)(2). 

Accordingly, all entities that currently 

handle or plan to handle Nethylpentylone have already been 

required to establish and implement the 

systems and processes required to 

specifically handle N-ethylpentylone. 

There are currently 31 unique 

registrations authorized to handle Nethylpentylone specifically, as well as a 

number of registered analytical labs that 

are authorized to handle schedule I 

controlled substances generally. Some 

of these entities are likely to be large 

entities. However, since DEA does not 

have information of registrant size and 

the majority of DEA registrants are small 

entities or are employed by small 

entities, DEA estimates a maximum of 

26 entities are small entities. Therefore, 

DEA conservatively estimates as many 

as 26 small entities are affected by this 

rule. 

A review of the 31 registrations 

indicates that all entities that currently 

handle N-ethylpentylone also handle 

other schedule I controlled substances, 

and thus they have established and 

implemented (or maintain) the systems 

and processes required to handle Nethylpentylone as a schedule I 

substance. Therefore, DEA anticipates 

that this rule will impose minimal or no 

economic impact on any affected 

entities, and, thus, will not have a 

significant economic impact on any of 

the 26 affected small entities. Therefore, 

DEA has concluded that this rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Unfunded Mandates Reform Act of 1995 

(UMRA) 

In accordance with 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. 

Determination To Make Rule Effective 

Immediately 

As indicated above, this rule finalizes 

the schedule I control status of Nethylpentylone that has already been in 

effect since the publication of an order 

in the Federal Register amending 21 

CFR 1308.11(h) to temporarily place Nethylpentylone in schedule I of the CSA 

pursuant to the temporary scheduling 

provisions of 21 U.S.C. 811(h). 83 FR 

44474. The August 2018 order was 

effective on the date of publication, and 

was based on findings by the thenActing Administrator that the temporary 

scheduling of N-ethylpentylone was 

necessary to avoid an imminent hazard 

to the public safety pursuant to 21 

U.S.C. 811(h)(1). Because this rule 

finalizes the control status of Nethylpentylone that has already been in 

effect for over two and half years, it does 

not alter the legal obligations of any 

person who handles this substance. 

Rather, it merely makes permanent the 

current scheduling status and 

corresponding legal obligations. 

Therefore, DEA is making the rule 

effective on the date of publication in 

the Federal Register, as any delay in the 

effective date is unnecessary and would 

be contrary to the public interest. 

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 (CRA) 

This rule is not a major rule as 

defined by the CRA, 5 U.S.C. 804. 

However, pursuant to the CRA, DEA is 

submitting a copy of this final rule 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 

■ 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. 

■ 2. In § 1308.11: 

■ a. Add paragraph (d)(86); and 

■ b. Remove and reserve paragraph 

(h)(36). 

The addition reads as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(86) N-ethylpentylone (Other names: ephylone, 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)pentan-1-one) ................................................... 7543 

* * * * * 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–12261 Filed 6–11–21; 8:45 am] 

BILLING CODE 4410–09–P 


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