Date="03/18/94" Citation="59 FR 12828" Group="legal" Type="RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION, JUSTICE" Subject="Schedules of Controlled Substances; Placement of Aminorex Into Schedul e I"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances; Placement of Aminorex 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 Aminorex Into Schedule I AGENCY: Drug Enforcement Administration, Justice. ACTION: Final rule. + ------------------------------------------------------------ SUMMARY: This final rule is issued by the Acting Administrator of the Drug Enforcement Administration (DEA) to place aminorex into Schedule I of the Controlled Substances Act (CSA). This action is based on findings made by the Acting 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 aminorex meets the statutory criteria for inclusion in Schedule I of the CSA. Since this substance has been temporarily scheduled in Schedule I, the regulatory control mechanisms and criminal sanctions of Schedule I continue to be applicable to the manufacture, distribution, importation and exportation of aminorex. EFFECTIVE DATE: March 18, 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: On September 21, 1992, the Administrator of the DEA published a final rule in the Federal Register (57 FR 43399) amending sec 1308.11(g) of Title 21 of the Code of Federal Regulations to temporarily place aminorex 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 aminorex was necessary to avoid an imminent hazard to the public safety. Section 201(h)(2) of 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 aminorex which would have expired on September 21, 1993, was extended to March 21, 1994 by the DEA Administrator (58 FR 44611). On August 20, 1993 in a notice of proposed rulemaking published in the Federal Register (58 FR 44311) and after a review of relevant data, the DEA Administrator proposed to place aminorex into Schedule I of the CSA pursuant to 21 U.S.C. 811(a). Prior to that time the DEA Administrator submitted data which DEA gathered regarding aminorex 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 DEA Administrator also requested a scientific and medical evaluation and a scheduling recommendation for aminorex from the Assistance Secretary for Health. By letter dated March 4, 1994, the Acting Administrator for the DEA received the scientific and medical evaluation and scheduling recommendation from the Assistant Secretary for Health. The Assistant Secretary recommended that aminorex 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 aminorex provided the opportunity for interested parties to submit comments, objections or requests for a hearing regarding the scheduling of aminorex. No comments, objections or requests for hearings were received regarding the scheduling of aminorez. Aminorex, also called aminoxaphen, 2-amino-5-phenyl-2-oxaoline, or 4,5-dihydro-5-phenyl-2-oxazolamine, is a phenethylamine in which the side chain has been cyclized into a substituted oxazoline. In the mid 1960's, it has marketed as an anorectic agent in Austria, West Germany, and Switzerland but was withdrawn from the European market when it became apparent that aminorex administration was associated with a high risk of fatal pulmonary hypertension. The Food and Drug Administration (FDA) has notified the DEA that there are no exemptions or appovals in effect under section 505 of the Federal Food, Drug, and Cosmetic Act for aminorex. A search of the scientific and medical literature revealed no indications of current medical use of aminorex in the United States. Aminorex is chemically and pharmacologically similar to amphetamine, methamphetamine, and cis-4-methylaminorex, all of which are controlled substances with high abuse potential. Like most central nervous system (CNS) stimulants, aminorex produces acute locomotor stimulation in rodents. In drug discrimination studies, aminorex fully substitutes for amphetamine in rats and monkeys and for cocaine in rats. The reinforcing effects of aminorex were evaluated in rhesus monkeys and baboons. Aminoex is self-administered in both experimental paradigms. Collectively, these data indicate that aminorex has an abuse liability and dependence profile similar to other potent Schedule I and II controlled CNS stimulants. The earliest confirmed trafficking of aminorex was in Florida in 1989. Since that time, forensic laboratories have identified aminorex in more than 70 exhibits submitted by law enforcement personnel in Florida, New Jersey, Michigan, Minnesota, Missouri, Pennsylvania, and South Carolina. Clandestine laboratories engaged in the synthesis of aminorex have been discovered in Florida, Pennsylvania, and South Carolina. Aminorex is orally active but the most common route of administration is via nasal insufflation. It is usually sold as amphetamine or methamphetamine. There has been one death in 1990 associated with aminorex abuse in the United States. Abuse of aminorex produces the same public health risks as those associated with other clandestinely produced stimulants such as methamphetamine with the additional risk factor of pulmonary hypertension. 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 Acting Administrator for the DEA, pursuant to the provisions of 21 U.S.C. 811 (a) and (b), finds that: (1) Aminorex has a high potential for abuse; (2) Aminorex has no currently accepted medical use in treatment in the United States; and, (3) There is a lack of accepted safety for use of aminorex under medical supervision. These findings are consistent with the placement of aminorex into Schedule I of the CSA. All regulations applicable to Schedule I substances continue to be in effect as of March 18, 1994 with respect to aminorex. This substance has been in Schedule I pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h) since September 21, 1992. The current applicable regulations are as follows: 1. Registration. Any person who manufactures, distributes, delivers, imports or exports aminorex or who engages in research or conducts instructional activities with respect to aminorex, 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. Aminorex must be manufactured, distributed and stored in accordance with secsec 1301.71-1301.76 title 21 of the Code of Federal Regulations. 3. Labeling and Packaging. All labels and labeling for commercial containers of aminorex 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 aminorex 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 aminorex shall take an inventory of all stocks of aminorex 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 aminorex. 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 aminorex. 8. Order Forms. All registrants involved in the distribution of aminorex 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 aminorex shall be in compliance with part 1312 of title 21 of the Code of Federal Regulations. 10. Criminal Liability. Any activity with respect to aminorex not authorized by, or in violation of, the CSA or the Controlled Substances Import and Export Act shall be unlawful. The Acting Administrator of the DEA hereby certifies that the placement of aminorex 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 or manufacture in the United States. In accordance with the provisions of 21 U.S.C. 811(a), this scheduling action is a formal rulemaking "on the record after opportunity for a hearing.'' 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 (OMB) 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 Federal 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), the Acting 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 (f)(1) through (f)(6) as (f)(2) through (f)(7) and by adding new paragraph (f)(1) to read as follows: sec 1308.11 Schedule I. * * * * * (f) * * * (1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl- 2-oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine) ... 1585 * * * * * sec 1308.11 [Amended] 3. Section 1308.11 is further amended by removing paragraph (g)(3) and redesignating paragraphs (g)(4) and (g)(5) as (g)(3) and (g)(4). Dated: March 14, 1994. Stephen H. Greene, Acting Administrator of Drug Enforcement. [FR Doc. 94-6320 Filed 3-17-94; 8:45 am] BILLING CODE 4410-09-M ------------------------------------------------------ The Contents entry for this article reads as follows: Schedules of controlled substances: Aminorex, 12828