Date="01/06/94" Citation="59 FR 671" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances Temporary Placement of 4-Bromo-2,5- dimethoxyphenethylamine Into Schedule I"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances Temporary Placement of 4- Bromo-2,5-dimethoxyphenethylamine 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 Temporary Placement of 4- Bromo-2,5-dimethoxyphenethylamine Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Final rule. + ------------------------------------------------------------ SUMMARY: The Acting Administrator of the Drug Enforcement Administration (DEA) is issuing this final rule to temporarily place 4-bromo- 2,5-dimethoxyphenethylamine into Schedule I of the Controlled Substances Act (CSA) pursuant to the emergency scheduling provisions of the CSA. This action is based on the finding by the Acting Administrator of the DEA that the placement of 4-bromo-2,5-dimethoxyphenethylam ine in Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. As a result of this rule, the criminal sanctions and regulatory controls of Schedule I substances under the CSA will be applicable to the manufacture, distribution, and possession of 4-bromo-2,5-dimethoxyphenethylamine. EFFECTIVE DATE: January 6, 1994. 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: The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473) amended section 201 of the Controlled Substances Act (CSA) (21 U.S.C. 811) to give the Attorney General the authority to temporarily place a substance into Schedule I of the CSA if it is found that such action is necessary to avoid an imminent hazard to the public safety. A substance may be temporarily scheduled under the emergency provision of the CSA if that substance is not listed in any other schedule under Section 202 of the CSA (21 U.S.C. 812) of if there is no approval or exemption in effect under 21 U.S.C. 355 of the Food, Drug, and Cosmetic Act for the substance. The Attorney General has delegated his authority under 21 U.S.C. 811 to the Administrator of the DEA (28 CFR 0.100). A notice of intent to temporarily place 4-bromo-2,5-dimethoxyphenethylamine into Schedule I of the CSA was published in the Federal Register on November 4, 1993, (58 FR 58819). The Administrator transmitted notice of his intention to temporarily place 4-bromo-2,5-dimethoxyphenethylamin e into Schedule I of the CSA to the Assistant Secretary for Health of the Department of Health and Human Services (HHS). In response to this notification, the Food and Drug Administration has advised DEA that there are no exemptions or approvals in effect under 21 U.S.C. 355 of the Food, Drug, and Cosmetic Act for 4-bromo- 2,5-dimethoxyphenethylamine and HHS has no objection to DEA's intention to temporarily place 4-bromo-2,5-dimethoxyphenethylamine into Schedule I of the CSA. No other comments were received regarding this matter. In accordance with 21 U.S.C. 811(h)(3), the Acting Administrator has considered the following factors regarding 4-bromo-2,5-dimethoxyphenethylam ine: (1) Its history and current pattern of abuse; (2) scope, duration and significance of abuse; and (3) what, if any, risk there is to the public health. 4-Bromo-2,5-dimethoxyphenethylamine is structurally similar to the Schedule I phenylisopropylamine hallucinogens, 4-methyl- 2,5-dimethoxyamphetamine (STP or DOM) and 4-bromo-2,5-dimethoxyphenethylamine (DOB). Like DOM and DOB, 4-bromo-2,5-dimethoxyphenethylamine displays high affinity for central serotonin receptors and is capable of substituting for either DOM or DOB in drug discrimination studies conducted in rats. These data suggest that 4-bromo-2,5- dimethoxyphenethylamine 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-dimethoxyphenethylamine 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. DEA first encountered 4-bromo-2,5-dimethoxyphenethylamine in Texas in 1979. Since that time, several other exhibits of 4-bromo-2,5-dimethoxyphenethylamine have been analyzed by DEA and state forensic laboratories in California, Arizona, Louisiana, Pennsylvania, Iowa, Oregon, Georgia, Tennessee and Florida. Clandestine laboratories producing 4-bromo-2,5-dimethoxyphenethylamine were seized in California in 1986 and in Arizona in 1992. It has been represented as 3,4-methylenedioxy-methamphetamine (MDMA) and has been sold in sugar cubes as LSD. More recently, it has been promoted as an aphrodisiac and distributed under the product name of NEXUS whose purported active ingredient is brominated cathinine. DEA has recently seized several thousand dosage units of this product. The continued clandestine production, illicit importation, distribution and abuse of 4-bromo-2,5-dimethoxyphenethylamine poses an imminent hazard to public safety. DEA is not aware of any commercial use for this substance in the United States. In accordance with the provisions of section 201(h) of the CSA (21 U.S.C. 811(h)) and 28 CFR 0.100 and based on a consideration of the requisite factors and other relevant information, the Acting Administrator finds that placement of 4-bromo-2,5-dimethoxyphenethylamin e into Schedule I of the CSA on a temporary basis is necessary to avoid an imminent hazard to the public safety. The following regulations are effective with respect to 4- bromo-2,5-dimethoxyphenethylamine on January 6, 1994, except for those individuals registered with DEA in accordance with part 1301 or part 1311 of title 21 of the Code of Federal Regulations, who currently possess 4-bromo-2,5-dimethoxyphenethylamine may continue to do so pending DEA's receipt of an application for amended registration no later than February 7, 1994: 1. Registration. Any person who manufactures, distributes, delivers, imports or exports 4-bromo-2,5-dimethoxyphenethylamine or who engages in research or conducts instructional activities with respect to 4-bromo-2,5-dimethoxyphenethylamine 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. 4-Bromo-2,5-dimethoxyphenethylamine must be manufactured, distributed and stored in accordance with secsec 1301.71 through 1301.76 of title 21 of the Code of Federal Regulations. 3. Labeling and Packaging. All labels and labeling for commercial containers of 4-bromo-2,5-dimethoxyphenethylamine must comply with requirements of secsec 1302.03 through 1302.05, 1302.7 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-dimethoxyphenethylamine must 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-dimethoxyphenethylamine is required to take an inventory of all stocks of this substance on hand pursuant to secsec 1304.11 through 1304.19 of title 21 of the Code of Federal Regulations. 6. Records. All registrants required to keep records pursuant to secsec 1304.21 through 1304.27 of title 21 of the Code of Federal Regulations must do so regarding 4-bromo-2,5-dimethoxyphenethylamine. 7. Reports. All registrants required to submit reports in accordance with secsec 1304.34 through 1304.37 of title 21 of the Code of Federal Regulations shall do so regarding 4-bromo-2,5- dimethoxyphenethylamine. 8. Order Forms. All registrants involved in the distribution of 4-bromo-2,5-dimethoxyphenethylamine must comply with the order form requirements of secsec 1305.01 through 1305.16 of title 21 of the Code of Federal Regulations. 9. Importation and Exportation. All importation and exportation of 4-bromo-2,5-dimethoxyphenethylamine must be in compliance with part 1312 of title 21 of the Code of Federal Regulations. 10. Criminal Liability. Any activity with 4-bromo-2,5-dimethoxyphenethylamin e not authorized by, or in violation of, the CSA or the Controlled Substances Import and Export Act occurring on or after January 6, 1994, is unlawful. The Acting Administrator of the DEA hereby certifies that the temporary placement of 4-bromo-2,5-dimethoxyphenethylamine 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 temporary control of a substance with no currently approved medical use in the United States. The temporary scheduling of 4-bromo-2,5-dimethoxyphenethylamine is not a significant regulatory action for the purposes of Executive Order (E.O.) 12866 of September 30, 1993. Drug scheduling matters are not subject to review by the Office of Management and Budget (OMB) pursuant to the provisions of E.O. 12866, section 3(d)(1). Accordingly, this proposed emergency scheduling action is not subject to provisions of E.O. 12778 which are contingent upon review by OMB. This regulation both responds to an emergency situation posing an imminent hazard to the public safety, and is essential to a criminal law enforcement function of the United States. This action has been analyzed in accordance with the principles and criteria in E.O. 12612, and it has been determined that the temporary placement of 4-bromo-2,5-dimethoxyphenethylamine into Schedule I of the CSA 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(h) of the CSA (21 U.S.C. 811(h)), and delegated to the Administrator of the DEA by the Department of Justice regulations (28 CFR 0.100), the Acting 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, 871b, unless otherwise noted. 2. Section 1308.11 is amended by adding paragraph (g)(5) to read as follows: sec 1308.11 Schedule I. * * * * * (g) * * * (5) 4-bromo-2,5-dimethoxyphenethylamine, its optical isomers, salts and salts of isomers-7392. Some other names: 2-(4-bromo- 2,5-dimethoxyphenyl)-1-aminoethane; alpha-desmethyl DOB; 2C- B. Dated: December 27, 1993. Stephen H. Greene, Acting Administrator of Drug Enforcement. [FR Doc. 94-234 Filed 1-5-94; 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; temporary placement into Schedule I, 671