Schedules of Controlled Substances; Placement of 4-Bromo-2,5- Dimethoxyphenethylamine Into Schedule I

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-126F]

Schedules of Controlled Substances; Placement of 4-Bromo-2,5-

Dimethoxyphenethylamine Into Schedule I

agency: Drug Enforcement Administration, Justice,

action: Final rule.

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summary: This final rule is issued by the Deputy Administrator of the

Drug Enforcement Administration (DEA) to place 4-bromo-2,5-

dimethoxyphenethylamine (4-bromo-2,5-DMPEA) into Schedule I of the

Controlled Substances Act (CSA). This action is based on findings made

by the Deputy Administrator of the DEA, after review and evaluation of

the relevant data by both DEA and the Assistant Secretary for Health,

Department of Health and Human Services, that 4-bromo-2,5-DMPEA meets

the statutory criteria for inclusion in Schedule I of the CSA. Since

this substance has been temporarily placed in Schedule I, the

regulatory controls and criminal sanctions of Schedule I will continue

to be applicable to the manufacture, distribution, importation,

exportation and possession of 4-bromo-2,5-DMPEA.

effective date: June 2, 1995.

for further information contact: Howard McClain, Jr., Chief, Drug and

Chemical Evaluation Section, Drug Enforcement Administration,

Washington, DC 20537, Telephone: (202) 307-7183.

supplementary information: On December 20, 1994, in a notice of

proposed rulemaking published in the Federal Register (59 FR 65521) and

after a review of relevant data, the Deputy Administrator of the DEA

proposed to place 4-bromo-2,5-DMPEA into Schedule I of the CSA pursuant

to 21 U.S.C. 811(a). Prior to this time, the Deputy Administrator

submitted data which DEA gathered regarding the trafficking, actual

abuse and relative potential for abuse for 4-bromo-2,5-DMPEA to the

Assistant Secretary for Health, delegate of the Secretary of the

Department of Health and Human Services. In accordance with 21 U.S.C.

811(b), the Deputy Administrator also requested a scientific and

medical evaluation and a scheduling recommendation for 4-bromo-2,5-

DMPEA from the Assistant Secretary for Health.

4-Bromo-2,5-DMPEA had been temporarily placed into Schedule I of

the CSA on January 6, 1994 for a period of one year (59 FR 671)

pursuant to the temporary scheduling provisions of the CSA (21 U.S.C.

811(h)). The temporary scheduling of 4-bromo-2,5-DMPEA subsequently was

extended for six months until July 6, 1995 (59 FR 65710). The temporary

scheduling was based on the finding by the DEA Acting Administrator

that such action was necessary to avoid an imminent hazard to the

public safety.

By letter dated April 28, 1995, the Deputy Administrator for the

DEA received the scientific and medical evaluation and a scheduling

recommendation from the Assistant Secretary for Health. The Assistant

Secretary recommended that 4-bromo-2,5-DMPEA be placed into Schedule I

of the CSA based on a scientific and medical evaluation of the

available data.

The notice or proposed rulemaking for 4-bromo-2,5-DMPEA provided

the opportunity for interested parties to submit comments, objections

or requests for a hearing regarding this scheduling. No comments,

objections or requests for hearings were received regarding the

scheduling of 4-bromo-2,5-DMPEA in the CSA.

4-Bromo-2,5-DMPEA is structurally similar to the Schedule I

phenylisopropylamine hallucinogens, 4-methyl-2,5-dimethoxyamphetamine

(DOM) and 4-bromo-2,5-dimethoxyamphetamine (DOB). Like DOM and DOB, 4-

bromo-2,5-DMPEA displays high affinity for central serotonin receptors

and is capable of substituting for DOM or DOB in drug discrimination

studies conducted in rats. These data suggest that 4-bromo-2,5-DMPEA is

a psychoactive substance capable of producing effects similar, though

not identical, to DOM and DOB. Data from human studies indicate that 4-

bromo-2,5-DMPEA is orally active at 0.1-0.2 mg/kg producing an

intoxication with considerable euphoria and sensory enhancement which

lasts for 6 to 8 hours. Higher doses have been reported to produce

intense and frightening hallucinations.

The DEA first encountered 4-bromo-2,5-DMPEA in 1979. Since that

time, several exhibits of 4-bromo-2,5-DMPEA have been analyzed by

Federal and state forensic laboratories in Arizona,

[[Page 28719]] California, Colorado, Georgia, Illinois, Iowa, Kentucky,

Oregon, Pennsylvania and Texas. Clandestine laboratories producing 4-

bromo-2,5-DMPEA were seized in California in 1986 and 1994 and in

Arizona in 1992. It has been represented as 3,4-

methylenedioxymethamphetamine (MDMA) and has been sold in adulterated

sugar cubes as LSD. 4-Bromo-2,5-DMPEA has been promoted as an

aphrodisiac and distributed under the product name of Nexus. DEA has

seized several thousand dosage units of this product.

The Food and Drug Administration (FDA) has notified the DEA that

there are no exemptions or approvals in effect under Section 505 of the

Federal Food, Drug, and Cosmetic Act for 4-bromo-2,5-DMPEA. A search of

the scientific and medical literature pertaining to 4-bromo-2,5-DMPEA

revealed no indications of current medical use in treatment in the

United States.

Based on the information gathered and reviewed by DEA and upon the

scientific and medical evaluation and recommendation of the Assistant

Secretary for Health, the Deputy Administrator for the DEA, pursuant to

the provisions of 21 U.S.C. 811 (a) and (b), finds that:

(1) 4-bromo-2,5-DMPEA has a high potential for abuse.

(2) 4-bromo-2,5-DMPEA has no currently accepted medical use in

treatment in the United States.

(3) There is a lack of accepted safety for use of 4-bromo-2,5-DMPEA

under medical supervision.

These findings are consistent with the placement of 4-bromo-2,5-

DMPEA into Schedule I of the CSA.

All regulations applicable to Schedule I substances continue to be

in effect as of June 2, 1995, with respect to 4-bromo-2,5-DMPEA. This

substance has been in Schedule I pursuant to the temporary scheduling

provisions of 21 U.S.C. 811(h) since January 6, 1994. The current

applicable regulations are as follows:

1. Registration. Any person who manufactures, distributes,

delivers, imports or exports 4-bromo-2,5-DMPEA or who engages in

research or conducts instructional activities with respect to 4-bromo-

2,5-DMPEA or who proposes to engage in such activities, must be

registered to conduct such activity in accordance with parts 1301 and

1311 of title 21 of the Code of Federal Regulations.

2. Security. 4-bromo-2,5-DMPEA must be manufactured, distributed

and stored in accordance with Secs. 1301.71-1301.76 of title 21 of the

Code of Federal Regulation.

3. Labeling and Packaging. All labels and labeling for commercial

containers of 4-bromo-2,5-DMPEA must comply with Secs. 1302.03-1302.05,

1302.07 and 1302.08 of title 21 of the Code of Federal Regulations.

4. Quotas. All persons required to obtain quotas for 4-bromo-2,5-

DMPEA shall submit applications pursuant to Secs. 1303.12 and 1303.22

of title 21 of the Code of Federal Regulations.

5. Inventory. Every registrant required to keep records and who

possesses any quantity of 4-bromo-2,5-DMPEA shall take an inventory of

all stocks of 4-bromo-2,5-DMPEA on hand pursuant to Secs. 1304.11-

1304.19 of title 21 of the Code of Federal Regulations.

6. Records. All registrants required to keep records pursuant to

Secs. 1304.21-1304.27 of title 21 of the Code of Federal Regulations

shall maintain such records with respect to 4-bromo-2,5-DMPEA.

7. Reports. All registrants required to submit reports pursuant to

Secs. 1304.34-1304.37 of title 21 of the Code of Federal Regulations

shall do so regarding 4-bromo-2,5-DMPEA.

8. Order Forms. All registrants involved in the distribution of 4-

bromo-2,5-DMPEA must comply with Secs. 1305.01-1305.16 of title 21 of

the Code of Federal Regulations.

9. Importation and Exportation. All importation and exportation of

4-bromo-2,5-DMPEA shall be in compliance with part 1312 of title 21 of

the Code of Federal Regulations.

10. Criminal Liability. Any activity with respect to 4-bromo-2,5-

DMPEA not authorized by, or in violation of, the CSA or the Controlled

Substances Import and Expert Act shall be unlawful.

The Deputy Administrator of the DEA hereby certifies that final

placement of 4-bromo-2,5-DMPEA into Schedule I of the CSA will have no

significant impact upon entities whose interests must be considered

under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This action

involves the control of a substance with no currently accepted medical

use in treatment in the United States.

In accordance with the provisions of 21 U.S.C. 811(a), this

scheduling action is a formal rulemaking. Such proceedings are

conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as

such, are exempt from review by the Office of Management and Budget

pursuant to Executive Order (E.O.) 12866, 3(d)(1).

This action has been analyzed in accordance with the principles and

criteria in E.O. 12612, and it has been determined that this final rule

does not have sufficient federalism implications to warrant the

preparation of a Federalism Assessment.

List of Subjects in 21 CFR Part 1308

Administrative practice and procedure, drug traffic control,

narcotics, prescription drugs.

Under the authority vested in the Attorney General by section

201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the

Administrator of the DEA by the Department of Justice regulations (28

CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28

CFR 0.104, the Deputy Administrator hereby orders that 21 CFR part 1308

be 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, 871b, unless otherwise noted.

2. Section 1308.11 is amended by redesignating the existing

paragraphs (d)(3) through (d)(30) as (d)(4) through (d)(31) and adding

a new paragraph (d)(3) to read as follows:

Sec. 1308.11 Schedule I.

* * * * *

(d) * * *

(3) 4-Bromo-2,5-dimethoxyphenethylamine

7392

Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)-1-

aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.

* * * * *

3. Section 1308.11 is further amended by removing paragraph (g)(3).

Dated: May 25, 1995.

Stephen H. Greene,

Deputy Administrator.

[FR Doc. 95-13454 Filed 6-1-95; 8:45 am]

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