Date="09/12/94" Citation="59 FR 46757" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances; Placement of Alpha-Ethyltryptamine Into Schedule I"

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.

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. + ------------------------------------------------------------ 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 ALPHA-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 secsec 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 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 AET 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 AET shall take an inventory of all stocks of AET 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 on AET. 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 AET. 8. Order Forms. All registrants involved in the distribution of AET 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 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; ALPHA-ethyl-1H- indole-3-ethanamine; 3-(2-aminobutyl) indole; ALPHA-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 ------------------------------------------------------ The Contents entry for this article reads as follows: Schedules of controlled substances: Alpha-ethyltryptamine, 46757