[Federal Register Volume 59, Number 53 (Friday, March 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6320]


[[Page Unknown]]

[Federal Register: March 18, 1994]


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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.

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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 Secs. 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 Secs. 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 Secs. 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 Secs. 1304.11-1304.19 of title 
21 of the Code of Federal Regulations.
    6. Records. All registrants required to keep records pursuant to 
Secs. 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 
Secs. 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 Secs. 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