[Federal Register Volume 59, Number 4 (Thursday, January 6, 1994)]
[Rules and Regulations]
[Pages 671-973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-234]
[[Page Unknown]]
[Federal Register: January 6, 1994]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
Schedules of Controlled Substances Temporary Placement of 4-
Bromo-2,5-dimethoxyphenethylamine Into Schedule I
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Final rule.
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SUMMARY: The Acting Administrator of the Drug Enforcement
Administration (DEA) is issuing this final rule to temporarily place 4-
bromo-2,5-dimethoxyphenethylamine into Schedule I of the Controlled
Substances Act (CSA) pursuant to the emergency scheduling provisions of
the CSA. This action is based on the finding by the Acting
Administrator of the DEA that the placement of 4-bromo-2,5-
dimethoxyphenethylamine in Schedule I of the CSA is necessary to avoid
an imminent hazard to the public safety. As a result of this rule, the
criminal sanctions and regulatory controls of Schedule I substances
under the CSA will be applicable to the manufacture, distribution, and
possession of 4-bromo-2,5-dimethoxyphenethylamine.
EFFECTIVE DATE: January 6, 1994.
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: The Comprehensive Crime Control Act of 1984
(Pub. L. 98-473) amended section 201 of the Controlled Substances Act
(CSA) (21 U.S.C. 811) to give the Attorney General the authority to
temporarily place a substance into Schedule I of the CSA if it is found
that such action is necessary to avoid an imminent hazard to the public
safety. A substance may be temporarily scheduled under the emergency
provision of the CSA if that substance is not listed in any other
schedule under Section 202 of the CSA (21 U.S.C. 812) of if there is no
approval or exemption in effect under 21 U.S.C. 355 of the Food, Drug,
and Cosmetic Act for the substance. The Attorney General has delegated
his authority under 21 U.S.C. 811 to the Administrator of the DEA (28
CFR 0.100).
A notice of intent to temporarily place 4-bromo-2,5-
dimethoxyphenethylamine into Schedule I of the CSA was published in the
Federal Register on November 4, 1993, (58 FR 58819). The Administrator
transmitted notice of his intention to temporarily place 4-bromo-2,5-
dimethoxyphenethylamine into Schedule I of the CSA to the Assistant
Secretary for Health of the Department of Health and Human Services
(HHS). In response to this notification, the Food and Drug
Administration has advised DEA that there are no exemptions or
approvals in effect under 21 U.S.C. 355 of the Food, Drug, and Cosmetic
Act for 4-bromo-2,5-dimethoxyphenethylamine and HHS has no objection to
DEA's intention to temporarily place 4-bromo-2,5-
dimethoxyphenethylamine into Schedule I of the CSA. No other comments
were received regarding this matter.
In accordance with 21 U.S.C. 811(h)(3), the Acting Administrator
has considered the following factors regarding 4-bromo-2,5-
dimethoxyphenethylamine: (1) Its history and current pattern of abuse;
(2) scope, duration and significance of abuse; and (3) what, if any,
risk there is to the public health.
4-Bromo-2,5-dimethoxyphenethylamine is structurally similar to the
Schedule I phenylisopropylamine hallucinogens, 4-methyl-2,5-
dimethoxyamphetamine (STP or DOM) and 4-bromo-2,5-
dimethoxyphenethylamine (DOB). Like DOM and DOB, 4-bromo-2,5-
dimethoxyphenethylamine displays high affinity for central serotonin
receptors and is capable of substituting for either DOM or DOB in drug
discrimination studies conducted in rats. These data suggest that 4-
bromo-2,5-dimethoxyphenethylamine 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-
dimethoxyphenethylamine 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.
DEA first encountered 4-bromo-2,5-dimethoxyphenethylamine in Texas
in 1979. Since that time, several other exhibits of 4-bromo-2,5-
dimethoxyphenethylamine have been analyzed by DEA and state forensic
laboratories in California, Arizona, Louisiana, Pennsylvania, Iowa,
Oregon, Georgia, Tennessee and Florida. Clandestine laboratories
producing 4-bromo-2,5-dimethoxyphenethylamine were seized in California
in 1986 and in Arizona in 1992. It has been represented as 3,4-
methylenedioxy-methamphetamine (MDMA) and has been sold in sugar cubes
as LSD. More recently, it has been promoted as an aphrodisiac and
distributed under the product name of NEXUS whose purported active
ingredient is brominated cathinine. DEA has recently seized several
thousand dosage units of this product.
The continued clandestine production, illicit importation,
distribution and abuse of 4-bromo-2,5-dimethoxyphenethylamine poses an
imminent hazard to public safety. DEA is not aware of any commercial
use for this substance in the United States.
In accordance with the provisions of section 201(h) of the CSA (21
U.S.C. 811(h)) and 28 CFR 0.100 and based on a consideration of the
requisite factors and other relevant information, the Acting
Administrator finds that placement of 4-bromo-2,5-
dimethoxyphenethylamine into Schedule I of the CSA on a temporary basis
is necessary to avoid an imminent hazard to the public safety.
The following regulations are effective with respect to 4-bromo-
2,5-dimethoxyphenethylamine on January 6, 1994, except for those
individuals registered with DEA in accordance with part 1301 or part
1311 of title 21 of the Code of Federal Regulations, who currently
possess 4-bromo-2,5-dimethoxyphenethylamine may continue to do so
pending DEA's receipt of an application for amended registration no
later than February 7, 1994:
1. Registration. Any person who manufactures, distributes,
delivers, imports or exports 4-bromo-2,5-dimethoxyphenethylamine or who
engages in research or conducts instructional activities with respect
to 4-bromo-2,5-dimethoxyphenethylamine or who proposes to engage in
such activities must be registered to conduct such activities in
accordance with parts 1301 and 1311 of title 21 of the Code of Federal
Regulations.
2. Security. 4-Bromo-2,5-dimethoxyphenethylamine must be
manufactured, distributed and stored in accordance with Secs. 1301.71
through 1301.76 of title 21 of the Code of Federal Regulations.
3. Labeling and Packaging. All labels and labeling for commercial
containers of 4-bromo-2,5-dimethoxyphenethylamine must comply with
requirements of Secs. 1302.03 through 1302.05, 1302.7 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-
dimethoxyphenethylamine must 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-dimethoxyphenethylamine is
required to take an inventory of all stocks of this substance on hand
pursuant to Secs. 1304.11 through 1304.19 of title 21 of the Code of
Federal Regulations.
6. Records. All registrants required to keep records pursuant to
Secs. 1304.21 through 1304.27 of title 21 of the Code of Federal
Regulations must do so regarding 4-bromo-2,5-dimethoxyphenethylamine.
7. Reports. All registrants required to submit reports in
accordance with Secs. 1304.34 through 1304.37 of title 21 of the Code
of Federal Regulations shall do so regarding 4-bromo-2,5-
dimethoxyphenethylamine.
8. Order Forms. All registrants involved in the distribution of 4-
bromo-2,5-dimethoxyphenethylamine must comply with the order form
requirements of Secs. 1305.01 through 1305.16 of title 21 of the Code
of Federal Regulations.
9. Importation and Exportation. All importation and exportation of
4-bromo-2,5-dimethoxyphenethylamine must be in compliance with part
1312 of title 21 of the Code of Federal Regulations.
10. Criminal Liability. Any activity with 4-bromo-2,5-
dimethoxyphenethylamine not authorized by, or in violation of, the CSA
or the Controlled Substances Import and Export Act occurring on or
after January 6, 1994, is unlawful.
The Acting Administrator of the DEA hereby certifies that the
temporary placement of 4-bromo-2,5-dimethoxyphenethylamine 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 temporary control of
a substance with no currently approved medical use in the United
States.
The temporary scheduling of 4-bromo-2,5-dimethoxyphenethylamine is
not a significant regulatory action for the purposes of Executive Order
(E.O.) 12866 of September 30, 1993. Drug scheduling matters are not
subject to review by the Office of Management and Budget (OMB) pursuant
to the provisions of E.O. 12866, section 3(d)(1). Accordingly, this
proposed emergency scheduling action is not subject to provisions of
E.O. 12778 which are contingent upon review by OMB. This regulation
both responds to an emergency situation posing an imminent hazard to
the public safety, and is essential to a criminal law enforcement
function of the United States.
This action has been analyzed in accordance with the principles and
criteria in E.O. 12612, and it has been determined that the temporary
placement of 4-bromo-2,5-dimethoxyphenethylamine into Schedule I of the
CSA 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(h) of the CSA (21 U.S.C. 811(h)), and delegated to the
Administrator of the DEA by the Department of Justice regulations (28
CFR 0.100), the Acting Administrator hereby amends 21 CFR part 1308 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 adding paragraph (g)(5) to read as
follows:
Sec. 1308.11 Schedule I.
* * * * *
(g) * * *
(5) 4-bromo-2,5-dimethoxyphenethylamine, its optical isomers, salts
and salts of isomers--7392. Some other names: 2-(4-bromo-2,5-
dimethoxyphenyl)-1-aminoethane; alpha-desmethyl DOB; 2C-B.
Dated: December 27, 1993.
Stephen H. Greene,
Acting Administrator of Drug Enforcement.
[FR Doc. 94-234 Filed 1-5-94; 8:45 am]
BILLING CODE 4410-09-M