VOL. 58, No. 9
VOL. 58, No. 9
Rules and Regulations
DEPARTMENT OF JUSTICE (DOJ)
Drug Enforcement Administration (DEA)
Drug Enforcement Administration (DEA)
21 CFR Part 1308
Schedules of Controlled Substances: Placement of Cathinone and 2,5-Dimethoxy-4-ethylamphetamine Into Schedule I
58 FR 4316
DATE: Thursday, January 14, 1993
ACTION: Final rule.
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SUMMARY: With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places cathinone and 2,5-dimethoxy-4-ethylamphetamine (DOET) into Schedule I of the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.). As a result of this rule, the regulatory controls and criminal sanctions of a Schedule I substance under the CSA will be applicable to the manufacture, distribution, and possession of cathinone and DOET. This action is taken to enable the United States to meet its obligations under the Convention on Psychotropic Substances.
EFFECTIVE DATE: February 16, 1993.
FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Cathinone and DOET are psychoactive substances which are regulated under Schedule I of the United Nations Convention on Psychotropic Substances, 1971. The United States is a signatory to that Convention. The CSA requires the Secretary of the Department of Health and Human Services (DHHS), should he concur with the scheduling decision of the United Nations Commission on Narcotic Drugs and should he determine that control measures under the CSA are not adequate to meet the requirements of the Convention, to recommend to the Attorney General that he initiate proceedings for scheduling the substance [see 21 U.S.C. 811(d)(3)(B)]. By letter dated July 2, 1987, the Assistant Secretary for Health, acting on behalf of the Secretary, recommended to the Administrator of the DEA that he initiate scheduling actions under the CSA to assure compliance with the international requirements. The Administrator proposed placing cathinone and DOET into Schedule I of the CSA in a notice which was published in the Federal Register (52 FR 41736, October 30, 1987). In response to the proposal, an individual requested a hearing if the placement of cathinone and DOET into Schedule I would affect his religious use of a number of psychoactive substances. Because the comment was not filed in a timely manner and the request for a hearing was not made in accordance with the procedures set forth in 21 CFR 1308.45, the request was denied.
The Administrator, by letter of December 13, 1988, requested a scientific and medical evaluation of the Assistant Secretary for Health [see 21 U.S.C. 811(b)]. The Assistant Secretary responded by letter of November 5, 1992 and recommended that cathinone and DOET be placed into Schedule I. Enclosed with the letter were documents which were entitled "Basis for the Recommendation for Control of Cathinone into Schedule I of the Controlled Substances Act" and "Basis for the Recommendation for Control of 2,5-Dimethoxy-4-ethylamphetamine (DOET) into Schedule I of the Controlled Substances Act". Each document presented an evaluation and scheduling recommendation which were based on a review of the factors which the CSA requires the Attorney General and the Secretary to consider [see 21 U.S.C. 811(c)]. The Assistant Secretary found that because cathinone's abuse potential is similar to those of the stimulants, amphetamine and methamphetamine, both of which have high potentials for abuse and are [*4317] controlled in Schedule II of the CSA, and because cathinone has not been accepted for medical use in treatment in the United States, cathinone should be controlled in Schedule I. In relation to DOET, the Assistant Secretary found that because its abuse potential is similar to that of the hallucinogens, mescaline, 2,5-dimethoxy-4-methylamphetamine and 2,5-dimethoxyamphetamine all of which are controlled in Schedule I of the CSA, 2,5-dimethoxy-4-ethylamphetamine (DOET) should be controlled similarly in Schedule I.
Cathinone is the major psychoactive component of the plant Catha edulis (khat). The young leaves of khat are chewed for a stimulant effect. Enactment of this rule results in the placement of any material which contains cathinone into Schedule I. When khat contains cathinone, khat is a Schedule I substance. During either the maturation or the decomposition of the plant material, cathinone is converted to cathine, a Schedule IV substance. In a previously published final rule, the Administrator stated that khat will be subject to the same Schedule IV controls as cathine, (see 53 FR 17459, May 17, 1988). When khat does not contain cathinone, but does contain cathine, khat is a Schedule IV substance.
While the clandestine synthesis of cathinone has not been encountered by the DEA, the illicit synthesis of the methyl analog, methcathinone, has been encountered at twelve clandestine laboratories. Methcathinone was placed into Schedule I on May 1, 1992 pursuant to 21 U.S.C. 811(h) (see 57 FR 18825, May 1, 1992). In January 1992, the DEA encountered a clandestine laboratory which had manufactured DOET.
Based on the information gathered and reviewed by the DEA, DHHS and the recommendation of the Assistant Secretary for Health, the Administrator of the DEA, pursuant to the provisions of 21 U.S.C. 811(a), finds that:
(A) Cathinone and DOET each have a high potential for abuse.
(B) Cathinone and DOET have no currently accepted medical use in treatment in the United States.
(C) There is a lack of accepted safety for use of cathinone or DOET under medical supervision.
The above findings are consistent with placement of cathinone and DOET into Schedule I of the CSA.
Regulations that are effective on and after February 16, 1993, and imposed on cathinone and DOET are as follows:
1. Registration. Any person who manufactures, distributes, delivers, imports or exports cathinone or DOET or who engages in research or conducts instructional activities with respect to these substances, 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. Cathinone and DOET must be manufactured, distributed and stored in accordance with §§ 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 cathinone and DOET must comply with the requirements of §§ 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 cathinone or DOET shall 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 cathinone or DOET shall take an inventory pursuant to §§ 1304.11-1304.19 of title 21 of the Code of Federal Regulations of all stocks of these substances on hand.
6. Records. All registrants required to keep records pursuant to §§ 1304.21-1304.27 of title 21 of the Code of Federal Regulations shall maintain such records on cathinone and DOET.
7. Reports. All registrants required to submit reports pursuant to §§ 1304.34-1304.37 of title 21 of the Code of Federal Regulations shall do so regarding cathinone and DOET.
8. Order Forms. All registrants involved in the distribution of cathinone or DOET must comply with the order form requirements of §§ 1305.01-1305.16.
9. Importation and Exportation. All importation and exportation of cathinone or DOET shall be in compliance with part 1312 of title 21 of the Code of Federal Regulations.
10. Criminal Liability. Any activity with respect to cathinone or DOET not authorized by, or in violation of, the CSA or the Controlled Substances Import and Export Act shall be unlawful.
Pursuant to 5 U.S.C. 605(b), the Administrator certifies that the placement of cathinone and DOET into Schedule I will have no impact upon small businesses or other entities whose interests must be considered under the Regulatory Flexibility Act (Pub. L. 96-354). This drug control action relates to the control of substances that have no legitimate use or manufacturer in the United States.
This action has been analyzed in accordance with the principles and criteria contained in E.O. 12612, and it has been determined that this matter does not have sufficient federalism implications to require the preparation of a Federalism Assessment.
In accordance with the provisions of 21 U.S.C. 811(d), this scheduling action is a formal rulemaking that is required by United States obligations under an international convention, namely the Convention on Psychotropic Substances, 1971. Such formal proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, have been exempted from the consultation requirements of Executive Order 12291 (46 FR 13193). Accordingly, this action is not subject to those provisions of E.O. 12778 which are contingent upon review by OMB. Nevertheless, the Administrator has determined that this is not a "major rule," as that term is used in E.O. 12291, and that it would otherwise meet the applicable standards of sections 2(a) and 2(b)(2) of E.O. 12778.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs.
Based upon the notification of the Secretary-General of the United Nations and in accordance with the recommendations of the Assistant Secretary for Health of the Department of Health and Human Services and under the authority vested in the Attorney General by 21 U.S.C. 811(a) and delegated to the Administrator by the regulations of the Department of Justice (28 CFR 0.100), the 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, 871(b) unless otherwise noted.
2. Section 1308.11 is amended by redesignating existing paragraphs (d)(3) through (d)(28) as (d)(4) through (d)(29) and adding new paragraph (d)(3) to read as follows:
* * * * *
§ 1308.11 Schedule I.
(d) * * *
amine . . . 7399
Some trade or other names: DOET [*4318]
* * * * *
3. Section 1308.11 is amended by redesignating paragraphs (f)(1) through (f)(4) as (f)(2) through (f)(5) and adding paragraph (f)(1) to read as follows:
§ 1308.11 Schedule I.
* * * * *
(f) * * *
(1) cathinone . . . 1235
Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone.
* * * * *
Dated: January 7, 1993.
Robert C. Bonner,
Administrator of Drug Enforcement.
[FR Doc. 93-877 Filed 1-13-93; 8:45 am]
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