[Federal Register Volume 59, Number 175 (Monday, September 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22417]


[[Page Unknown]]

[Federal Register: September 12, 1994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

 

Schedules of Controlled Substances; Placement of Alpha-
Ethyltryptamine 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 alpha-ethyltryptamine 
(AET) 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 the DEA 
and the Assistant Secretary for Health, Department of Health and Human 
Services, that AET meets the statutory criteria for inclusion in 
Schedule I of the CSA. Since this substance has been temporarily placed 
into Schedule I, the regulatory control mechanisms and criminal 
sanctions of Schedule I continue to be applicable to the manufacture, 
distribution, importation and exportation of AET.

EFFECTIVE DATE: September 12, 1994.

FOR FURTHER INFORMATION CONTACT:
Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug 
Enforcement Administration, Washington, D.C. 20537, Telephone: (202) 
307-7183.

SUPPLEMENTARY INFORMATION: On March 12, 1993, the Administrator of the 
DEA published a final rule in the Federal Register (58 FR 13533) 
amending Sec. 1308.11(g) of Title 21 of the Code of Federal Regulations 
to temporarily place AET into Schedule I of the CSA pursuant to the 
temporary scheduling provisions of 21 U.S.C. 811(h). This final rule, 
which became effective on the date of publication, was based on a 
finding by the Administrator that the temporary scheduling of AET was 
necessary to avoid an imminent hazard to the public safety. The CSA (21 
U.S.C. 811(h)(2)) requires that the temporary scheduling of a substance 
expires at the end of one year from the effective date of the order. 
However, if proceedings to schedule a substance pursuant to 21 U.S.C. 
811(a)(1) have been initiated and are pending, the temporary scheduling 
of a substance may be extended for up to six months. Under this 
provision, the temporary scheduling of AET which would have expired on 
March 12, 1994, was extended to September 12, 1994 by the Acting DEA 
Administrator (59 FR 10720).
    On March 7, 1994 in a notice of proposed rulemaking published in 
the Federal Register (59 FR 10718) and after a review of relevant data, 
the Acting DEA Administrator proposed to place AET into Schedule I of 
the CSA pursuant to 21 U.S.C. 811(a). Prior to that time the Acting DEA 
Administrator submitted data which DEA gathered regarding AET 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 Acting DEA Administrator also requested a scientific and 
medical evaluation and a scheduling recommendation for AET from the 
Assistant Secretary for Health.
    By letter dated August 30, 1994, the Deputy Administrator for the 
DEA received the scientific and medical evaluation and scheduling 
recommendation from the Assistant Secretary for Health. The Assistant 
Secretary recommended that AET be placed into Schedule I of the CSA 
based on a scientific and medical evaluation of the available data.
    The notice of proposed rulemaking for AET provided the opportunity 
for interested parties to submit comments, objections or requests for a 
hearing regarding the scheduling of AET. No comments, objections or 
requests for hearings were received regarding the scheduling of AET.
    Alpha-ethyltryptamine has been classified as a tryptamine 
hallucinogen. Chemically it is -ethyl-1H-indole-3-ethanamine 
or 3-(2-aminobutyl)indole. It is structurally similar to N,N-
dimethyltryptamine (DMT) and N,N-diethyltryptamine (DET) both of which 
are controlled in Schedule I of the CSA. Available data indicate that 
AET produces some pharmacological effects qualitatively similar to 
those of other Schedule I hallucinogens. Recent data suggests that AET 
may produce neurotoxicity similar to the neurotoxic effects produced by 
MDMA (3,4-methylenedioxymethamphetamine) and PCA (para-
chloroamphetamine).
    Alpha-ethyltryptamine acetate was marketed by the Upjohn Company in 
1961 as an antidepressant under the trade name of Monase. After less 
than one year of marketing, Upjohn withdrew its New Drug Application 
when it became apparent that Monase administration was associated with 
the development of agranulocytosis. 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 AET. A search of the scientific and medical literature revealed no 
indications of current medical use of AET in the United States.
    The DEA first encountered AET in 1986 at a clandestine laboratory 
in Nevada. Several exhibits of AET have been analyzed by the DEA and 
state forensic laboratories since 1989. Individuals in Colorado and 
Arizona have purchased several kilograms of this substance as the 
acetate salt from chemical supply companies and have distributed and 
sold quantities to individuals for the purpose of human consumption. 
Touted as a MDMA-like substance, it has been trafficked as ``TRIP'' or 
``ET''. Distribution has been primarily among high school and college-
aged individuals. In Arizona, the death of a nineteen year old female 
was attributed to acute AET toxicity. Illicit use of AET has been 
documented in both Germany and Spain where at least two deaths have 
resulted from AET overdose.
    Based upon the investigation and review conducted by DEA and upon 
the scientific and medical evaluation and recommendation of the 
Assistant Secretary for Health received in accordance with 21 U.S.C. 
811(b), the Deputy Administrator for the DEA, pursuant to the 
provisions of 21 U.S.C. 811 (a) and (b), finds that:
    (1) AET has a high potential for abuse;
    (2) AET has no currently accepted medical use in treatment in the 
United States; and,
    (3) There is a lack of accepted safety for use of AET under medical 
supervision.

These findings are consistent with the placement of AET into Schedule I 
of the CSA.
    All regulations applicable to Schedule I substances continue to be 
in effect as of September 12, 1994 with respect to AET. This substance 
has been in Schedule I pursuant to the temporary scheduling provisions 
of 21 U.S.C. 811(h) since March 12, 1993. The current applicable 
regulations are as follows:
    1. Registration. Any person who manufactures, distributes, 
delivers, imports or exports AET or who engages in research or conducts 
instructional activities with respect to AET, 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. Alpha-ethyltryptamine must be manufactured, 
distributed and stored in accordance with Secs. 1301.71-1301.76 of 
Title 21 of the Code of Federal Regulations.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of AET 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 AET 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 AET shall take an inventory of all stocks of 
AET 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 on AET.
    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 AET.
    8. Order Forms. All registrants involved in the distribution of AET 
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 
AET shall be in compliance with part 1312 of Title 21 of the Code of 
Federal Regulations.
    10. Criminal Liability. Any activity with respect to AET not 
authorized by, or in violation of, the CSA or the Controlled Substances 
Import and Export Act shall be unlawful.
    The Deputy Administrator of the DEA hereby certifies that the 
placement of AET 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 
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 12866, 3(d)(1).
    This action has been analyzed in accordance with the principles and 
criteria in Executive Order 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 by the Administrator to the Deputy 
Administrator pursuant to 28 CFR 0.104 (59 FR 23637 (May 6, 1994)), the 
Deputy Administrator hereby orders that 21 CFR Part 1308 be amended as 
follows:

PART 1308--[AMENDED]

    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 paragraphs (d)(1) 
through (d)(29) as (d)(2) through (d)(30) and by adding paragraph 
(d)(1) to read as follows:


Sec. 1308.11  Schedule I.

* * * * *
    (d) * * *

(1) Alpha-ethyltryptamine
7249

    Some trade or other names: etryptamine; Monase; -ethyl-1H-
indole-3-ethanamine; 3-(2-aminobutyl) indole; -ET; and AET.
* * * * *


Sec. 1308.11  [Amended]

    3. Section 1308.11 is further amended by removing paragraph (g)(3) 
and redesignating paragraph (g)(4) as (g)(3).

    Dated: September 2, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-22417 Filed 9-9-94; 8:45 am]
BILLING CODE 4410-09-M