[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
