Date="06/02/95" Citation="60 FR 28717" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE," Subject="Schedules of Controlled Substances; Placement of 4-Bromo-2,5-Dimethoxyphenethylamine Into Schedule I"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [DEA-126F] Schedules of Controlled Substances; 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 [DEA-126F] Schedules of Controlled Substances; Placement of 4-Bromo-2,5- Dimethoxyphenethylamine 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 4-bromo- 2,5-dimethoxyphenethylamine (4-bromo-2,5-DMPEA) 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 DEA and the Assistant Secretary for Health, Department of Health and Human Services, that 4-bromo-2,5-DMPEA meets the statutory criteria for inclusion in Schedule I of the CSA. Since this substance has been temporarily placed in Schedule I, the regulatory controls and criminal sanctions of Schedule I will continue to be applicable to the manufacture, distribution, importation, exportation and possession of 4-bromo-2,5-DMPEA. EFFECTIVE DATE: June 2, 1995. 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: On December 20, 1994, in a notice of proposed rulemaking published in the Federal Register (59 FR 65521) and after a review of relevant data, the Deputy Administrator of the DEA proposed to place 4-bromo-2,5-DMPEA into Schedule I of the CSA pursuant to 21 U.S.C. 811(a). Prior to this time, the Deputy Administrator submitted data which DEA gathered regarding the trafficking, actual abuse and relative potential for abuse for 4-bromo-2,5-DMPEA 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 Deputy Administrator also requested a scientific and medical evaluation and a scheduling recommendation for 4-bromo-2,5-DMPEA from the Assistant Secretary for Health. 4-Bromo-2,5-DMPEA had been temporarily placed into Schedule I of the CSA on January 6, 1994 for a period of one year (59 FR 671) pursuant to the temporary scheduling provisions of the CSA (21 U.S.C. 811(h)). The temporary scheduling of 4-bromo- 2,5-DMPEA subsequently was extended for six months until July 6, 1995 (59 FR 65710). The temporary scheduling was based on the finding by the DEA Acting Administrator that such action was necessary to avoid an imminent hazard to the public safety. By letter dated April 28, 1995, the Deputy Administrator for the DEA received the scientific and medical evaluation and a scheduling recommendation from the Assistant Secretary for Health. The Assistant Secretary recommended that 4-bromo-2,5- DMPEA be placed into Schedule I of the CSA based on a scientific and medical evaluation of the available data. The notice or proposed rulemaking for 4-bromo-2,5-DMPEA provided the opportunity for interested parties to submit comments, objections or requests for a hearing regarding this scheduling. No comments, objections or requests for hearings were received regarding the scheduling of 4-bromo-2,5-DMPEA in the CSA. 4-Bromo-2,5-DMPEA is structurally similar to the Schedule I phenylisopropylamine hallucinogens, 4-methyl-2,5-dimethoxyamphetamine (DOM) and 4-bromo-2,5-dimethoxyamphetamine (DOB). Like DOM and DOB, 4-bromo-2,5-DMPEA displays high affinity for central serotonin receptors and is capable of substituting for DOM or DOB in drug discrimination studies conducted in rats. These data suggest that 4-bromo-2,5-DMPEA 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-DMPEA 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. The DEA first encountered 4-bromo-2,5-DMPEA in 1979. Since that time, several exhibits of 4-bromo-2,5-DMPEA have been analyzed by Federal and state forensic laboratories in Arizona, ---- page 28719 ---- California, Colorado, Georgia, Illinois, Iowa, Kentucky, Oregon, Pennsylvania and Texas. Clandestine laboratories producing 4- bromo-2,5-DMPEA were seized in California in 1986 and 1994 and in Arizona in 1992. It has been represented as 3,4-methylenedioxymethamphetamine (MDMA) and has been sold in adulterated sugar cubes as LSD. 4-Bromo-2,5-DMPEA has been promoted as an aphrodisiac and distributed under the product name of Nexus. DEA has seized several thousand dosage units of this product. 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 4-bromo- 2,5-DMPEA. A search of the scientific and medical literature pertaining to 4-bromo-2,5-DMPEA revealed no indications of current medical use in treatment in the United States. Based on the information gathered and reviewed by DEA and upon the scientific and medical evaluation and recommendation of the Assistant Secretary for Health, the Deputy Administrator for the DEA, pursuant to the provisions of 21 U.S.C. 811 (a) and (b), finds that: (1) 4-bromo-2,5-DMPEA has a high potential for abuse. (2) 4-bromo-2,5-DMPEA has no currently accepted medical use in treatment in the United States. (3) There is a lack of accepted safety for use of 4-bromo- 2,5-DMPEA under medical supervision. These findings are consistent with the placement of 4-bromo- 2,5-DMPEA into Schedule I of the CSA. All regulations applicable to Schedule I substances continue to be in effect as of June 2, 1995, with respect to 4-bromo- 2,5-DMPEA. This substance has been in Schedule I pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h) since January 6, 1994. The current applicable regulations are as follows: 1. Registration. Any person who manufactures, distributes, delivers, imports or exports 4-bromo-2,5-DMPEA or who engages in research or conducts instructional activities with respect to 4-bromo-2,5-DMPEA 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. 4-bromo-2,5-DMPEA must be manufactured, distributed and stored in accordance with secsec 1301.71-1301.76 of title 21 of the Code of Federal Regulation. 3. Labeling and Packaging. All labels and labeling for commercial containers of 4-bromo-2,5-DMPEA 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 4-bromo- 2,5-DMPEA 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 4-bromo-2,5-DMPEA shall take an inventory of all stocks of 4-bromo-2,5-DMPEA 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 with respect to 4-bromo-2,5-DMPEA. 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 4-bromo-2,5-DMPEA. 8. Order Forms. All registrants involved in the distribution of 4-bromo-2,5-DMPEA 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 4-bromo-2,5-DMPEA shall be in compliance with part 1312 of title 21 of the Code of Federal Regulations. 10. Criminal Liability. Any activity with respect to 4-bromo- 2,5-DMPEA not authorized by, or in violation of, the CSA or the Controlled Substances Import and Expert Act shall be unlawful. The Deputy Administrator of the DEA hereby certifies that final placement of 4-bromo-2,5-DMPEA 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 treatment 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 (E.O.) 12866, 3(d)(1). This action has been analyzed in accordance with the principles and criteria in E.O. 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 to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby orders that 21 CFR part 1308 be amended 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 redesignating the existing paragraphs (d)(3) through (d)(30) as (d)(4) through (d)(31) and adding a new paragraph (d)(3) to read as follows: sec 1308.11 Schedule I. * * * * * (d) * * * (3) 4-Bromo-2,5-dimethoxyphenethylamine.................7392 Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)- 1-aminoethane; alpha-desmethyl DOB; 2C-B, Nexus. * * * * * 3. Section 1308.11 is further amended by removing paragraph (g)(3). Dated: May 25, 1995. Stephen H. Greene, Deputy Administrator. [FR Doc. 95-13454 Filed 6-1-95; 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, 28717