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.

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) 3077183.

SUPPLEMENTARY INFORMATION: The Comprehensive Crime Control Act of 1984 (Pub.
L. 98473) 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 0.10.2 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  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 
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 
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  1304.11
through 1304.19 of title 21 of the Code of Federal Regulations.

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

 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; 2CB.

Dated: December 27, 1993.

Stephen H. Greene,

Acting Administrator of Drug Enforcement.

[FR Doc. 94234 Filed 1594; 8:45 am]

BILLING CODE 441009M


