[Federal Register Volume 60, Number 106 (Friday, June 2, 1995)]
[Rules and Regulations]
[Pages 28718-28719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13454]
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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]
BILLING CODE 4410-09-M
