HaCKeRz Kr0nlcKLeZ 1/HaCKeRz Kr0nlcKLeZ.iso/drugs/60.fr.28717

Text File | 1996-05-06 | 11.4 KB | 246 lines

<ARTICLE>
Date="06/02/95"
Citation="60 FR 28717"
Group="legal"
Type="RULE"
Department="DEPARTMENT OF JUSTICE"
Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE,"
Subject="Schedules of Controlled Substances; Placement of 4-Bromo-2,5-Dimethoxyphenethylamine Into Schedule I"
<HEADER>
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.
</HEADER>
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.
+
------------------------------------------------------------
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: [phone].

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 secsec 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 secsec 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 secsec 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 secsec 1304.11-1304.19 of title 21 of the Code of Federal Regulations.
   6. Records. All registrants required to keep records pursuant
to secsec 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 secsec 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 secsec 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


------------------------------------------------------
The Contents entry for this article reads as follows:

Schedules of controlled substances:
  4-Bromo-2,5-dimethoxyphenethylamine, 28717
</ARTICLE>

.