[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
