[Federal Register: April 4, 2003 (Volume 68, Number 65)]
[Rules and Regulations]
[Page 16427-16430]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap03-8]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-238F]
Schedules of Controlled Substances: Temporary Placement of alpha-
methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine into Schedule
I
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
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SUMMARY: The Deputy Administrator of the Drug Enforcement
Administration (DEA) is issuing this final rule to temporarily place
alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine
(5-MeO-DIPT) into Schedule I of the Controlled Substances Act (CSA)
pursuant to the temporary scheduling provisions of the CSA. This final
action is based on a finding by the DEA Deputy Administrator that the
placement of AMT and 5-MeO-DIPT into 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 AMT and 5-MeO-DIPT.
EFFECTIVE DATE: April; 4. 2003.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, (202) 307-7183.
[[Page 16428]]
SUPPLEMENTARY INFORMATION:
Under What Authority Are AMT and 5-MeO-DIPT Being Temporarily
Scheduled?
The Comprehensive Crime Control Act of 1984 (Pub. L. 98-473), which
was signed into law on October 12, 1984, amended section 201 of the CSA
(21 U.S.C. 811) to give the Attorney General the authority to
temporarily place a substance into Schedule I of the CSA for one year
without regard to the requirements of 21 U.S.C. 811(b) if he finds that
such action is necessary to avoid an imminent hazard to the public
safety. The Attorney General may extend the temporary scheduling up to
6 months. A substance may be temporarily scheduled under the emergency
provisions of the CSA if that substance is not listed in any other
schedule under section 202 of the CSA (21 U.S.C. 812) or if there is no
exemption or approval in effect under 21 U.S.C. 355 for the substance.
The Attorney General has delegated his authority under 21 U.S.C. 811 to
the Administrator of DEA (28 CFR 0.100). The Administrator has
redelegated this function to the Deputy Administrator, pursuant to 28
CFR 0.104.
A notice of intent to temporarily place AMT and 5-MeO-DIPT into
Schedule I of the CSA was published in the Federal Register on January
28, 2003 (68 FR 4127). The Deputy Administrator transmitted notice of
his intention to temporarily place AMT and 5-MeO-DIPT 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
exceptions or approvals in effect under 21 U.S.C. 355 of the Food, Drug
and Cosmetic Act for AMT and 5-MeO-DIPT and HHS has no objection to
DEA's intention to temporarily place alpha-methyltryptamine and 5-
methoxy-N,N-diisopropytryptamine into Schedule I of the CSA.
What Factors Were Considered in the Determination To Temporarily
Schedule AMT and 5-MeO-DIPT?
As set forth under 21 U.S.C. 811(h), the Deputy Administrator has
considered the available data and the following three factors under the
CSA (21 U.S.C. 811(c)) that are required for a determination to
temporarily schedule a substance:
4. Its history and current pattern of abuse;
5. The scope, duration, and significance of abuse; and
6. What, if any, risk there is to the public health.
Additionally, DEA has considered the three criteria for placing a
substance into Schedule I of the CSA (21 U.S.C. 812). The data
available and reviewed for AMT and 5-MeO-DIPT indicate that they have a
high potential for abuse, no currently accepted medical use in
treatment in the United States and are not safe for use under medical
supervision.
What Are AMT and 5-MeO DIPT?
Alpha-methyltryptamine (AMT) and 5-methosy-N, N-
diisopropytryptamine (5-MeO-DIPT) are tryptamine (indoleethylamine)
derivatives and share several similarities with the Schedule I
tryptamine hallucinogens, alpha-ethyltryptamine (AET) and N, N-
demethyltryptamine (DMT), respectively. Several other tryptamines also
produce hallucinogenic/stimulant effects and are controlled as Schedule
I substances under the CSA (bufotenine, diethyltryptamine, psilocybin
and psilocyn). Although tryptamine itself appears to lack consistent
hallucinogenic/stimulant effects, substitutions on the indole ring and
the ethylamine side-chain of this molecule result in pharmacologically
active substances (McKenna and Towers, J. Psychoactive Drugs, 16:347-
358, 1984).
The chemical structures of AMT and 5-MeO-DIPT possess the critical
features necessary for hallucinogenic/stimulant activity. Thus, both
AMT and 5-MeO-DIPT are likely to have a pharmacological profile
substantially similar to other Schedule I tryptamine derivatives such
as DMT and AET. In drug discrimination studies, both AMT and 5-MeO-DIPT
substitute for 1-(2,5-dimethosy-4-methylphenyl)-aminopropane (DOM), a
phenethylamine-based hallucinogen in Schedule I of the CSA. The
potencies of DOM-like discriminative stimulus effects of these and
several other similar tryptamine derivatives correlate well with their
hallucinogenic potencies in humans (Glennon et al., Eur. J. Pharmacol.
86: 453-459, 1983).
AMT shares other pharmacological properties with Schedule I
hallucinogens such as AET, AMT increases systolic and diastolic
arterial blood pressures. The behavioral effects of orally administered
AMT (20 mg) in humans are slow in onset, occurring after 3 to 4 hours,
and gradually subsiding after 12 to 24 hours, but may last up to 2 days
in some subjects. The majority of the subjects report nervous tension,
irritability, restlessness, inability to sleep, blurry vision,
mydriasis and equate the effects of a 20 mg dose to those of 50
micrograms of lysergic acid diethylamide (LSD) (Hollister et al., J.
Nervous Ment. Dis., 131:428-434, 1960; Murphree et al., Clin.
Pharmacol. Ther., 2: 722-726, 1961). AMT also produces hallucinations
and dextroamphetamine-like mood elevating effects.
5-MeO-DIPT also produces pharmacological effects similar to those
of other Schedule I hallucinogens such as DMT. The synthesis and
preliminary human psychopharmacology study on 5-MeO-DIPT was first
published in 1981 (Shulgin and Carter, Comm. Physhopharmacol. 4: 363-
369, 1981), 5-MeO-DIPT is an orally active hallucinogen. Following oral
administration of 6-10 mg. 5-MeO-DIPT produces subjective effects with
an onset at about 20-30 minutes, a peak at about 1-1.5 hours and a
duration of about 3-6 hours. Subjects who have been administered 5-MeO-
DIPT are talkative and disinhibited. 5-MeO-DIPT causes mydriasis. High
doses of 5-MeO-DIPT produce nausea, jaw clenching, muscle tension and
overt hallucinations with both auditory and visual distortions.
Why Are AMT and 5-MeO-DIPT Being Controlled?
The continued trafficking and abuse of AMT and 5-;MeO-DIPT pose an
imminent hazard to public safety. The popularity and use of
hallucinogenic/stimulant substances at raves (all-night dance parties)
and other social venues have been a major problem in Europe since the
1990s. In the past several years, this activity has spread to the
United States. The Schedule I controlled substance 3,4-
methylendioxymethamphetamine (MDMA or Ecstasy) and its analogues are
the most frequently abused drugs at these raves. Their abuse has been
associated with both acute and long-term public health and safety
problems. Raves have also become venues for the trafficking and abuse
of new, non-controlled substances distributed as legal substitutes for,
or in addition to, MDMA. 5-MeO-DIPT and AMT belong to such a group of
substances.
Data gathered from published studies, supplemented by reports on
Internet websites indicate that these are often administered orally at
doses ranging from 15-40 mg for AMT ant 6-20 mg for 5-MeO-DIPT . Other
routes of administration include smoking and snorting. Data from law-
enforcement officials indicate that 5-MeO-DIPT is often sold as
``Foxy'' or ``Foxy Methoxy'', while MAT has been sold as ``Spirals'' at
lease in one case. Both substances have been commonly
[[Page 16429]]
encountered in tablet and capsule forms.
According to forensic laboratory data, the first encounter of AMT
and 5-MeO-DIPT occurred in 1999. Since then, law enforcement officials
in Arizona, California, Colorado, Delaware, Florida, Idaho, Illinois,
Iowa, New Jersey, Oregon, Texas, Virginia, Washington, Wisconsin and
the District of Columbia have encountered these substances. According
to the Florida Department of Law Enforcement (FDLE), the abuse by teens
and young adults of AMT and 5-MeO-DIPT is an emerging problem. There
have been reports of abuse of AMT and 5-MeO-DIPT at clubs and raves in
Arizona, California, Florida and New York. Many tryptamine-based
substances are illicitly available from United States and foreign
chemical companies and from individuals through the Internet. A gram of
AMT or 5-MeO-DIPT as bulk powdered costs less than $150 from illicit
sources on the Internet. DEA is not aware of any legitimate medical or
scientific use of AMT and 5-MeO-DIPT. There is recent evidence
suggesting the attempted clandestine production of AMT and 5-MeO-DIPT
in Nevada, Virginia and Washington, DC.
AMT and 5-MeO-DIPT share substantial chemical and pharmacological
similarities with other Schedule I tryptamine-based hallucinogens in
Schedule I of the CSA (AET and DMT). This makes it likely that these
drugs cause similar health hazards. Tryptamine, the parent molecule of
AMT and 5-MeO-DIPT, is known to produce convulsions and death in
animals (Tedeschi et al., J. Pharmacol. Exp. Ther. 126:223-232, 1959).
AMT and 5-MeO-DIPT, similar to other tryptamine- or phenethylamine-
based hallucinogens, through the alteration of sensory perception and
judgement can pose serious health risks to the user and the general
public. further, there have been several self-reports on Internet Web
sites describing the reported abuse of these substances in combination
with other controlled drugs, namely MDMA, marijuana, gamma
hydroxybutyric acid (GHB) and 2,5-dimethoxy-4-(n)-
propylthiophenethylamine (2C-T-7). This practice of drug abuse
involving combinations poses additional health risks to the users and
the general public. Available information indicates that AMT and 5-MeO-
DIPT lack any approved therapeutic use in the United States. The safety
of these substances for use in humans has not been studied.
What Is the Effect of This Final Rule?
With the issuance of this final order, AMT and 5-MeO-DIPT become
subject to regulatory controls and administrative, civil and criminal
sanctions applicable to the manufacture, distribution, dispensing,
importing and exporting of a Schedule I controlled substance.
1. Registration. Any person who manufactures, distributes,
dispenses, imports or exports AMT and 5-MeO-DIPT or who engages in
research or conducts instructional activities with respect to AMT and
5-MeO-DIPT or who proposes to engage in such activities must submit an
application for Schedule I registration in accordance with part 1301 of
Title 21 of the Code of Federal Regulations (CFR) by May 5, 2003.
2. Security. AMT and 5-MeO-DIPT are subject to Secheule I security
requirements and must be manufactured, distributed and stored in
accordance with Sec. Sec. 1301.71, 1301.72(a), (c), and (d), 1301.73,
1301.74, 1301.75 (a) and (c) and 1301.76 of Title 21 Code of Federal
Regulations.
3. Labeling and packaging. All labels and labeling for commercial
containers of AMT and 5-MeO-DIPT which are distributed on or after May
5, 2003 shall comply with requirements of Sec. Sec. 1302.03-1302.07 of
Title 21 of the Code Federal Regulations.
4. Quotas. Quotas for AMT and 5-MeO-DIPT are established pursuant
to part 1303 of title 21 of the code of Federal Regulations.
5. Inventory. Every registrant required to keep records who
possesses any quantity of AMT and 5-MeO-DIPT is required to keep
inventory of all stocks of the substances on hand pursuant to
Sec. Sec. 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of
Federal Regulations. Every registrant who desires registration in
Schedule I for AMT and 5-MeO-DIPT shall conduct an inventory of all
stocks of AMT and 5-MeO-DIPT on or before May 5, 2003.
6. Records. All registrants are required to keep records pursuant
to Sec. Sec. 1304.03, 1304.04 and Sec. Sec. 1304.21-1304.23 of Title
21 of the Code of Federal Regulations.
7. Reports. All registrants required to submit reports in
accordance with Sec. Sec. 1304.31 through Sec. Sec. 1304.33 of Title
21 of the Code Federal Regulations shall do so regarding AMT and 5-MeO-
DIPT.
8. Order Forms. All registrants involved in the distribution of AMT
and 5-MeO-DIPT must comply with the order form requirements of part
1305 of Title 21 of the Code of Federal Regulations.
9. Importation and Exportation. All importation and exportation of
AMT and 5-MeO-DIPT shall be in compliance with part 1312 of Title 21 of
the Code of Federal Regulations.
10. Criminal Liability. Any activity with AMT and 5-MeO-DIPT not
authorized by, or in violation of, the CSA or the Controlled Substances
Import and Export Act occurring on or after April 4, 2003 is unlawful.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)), has reviewed this regulation, and by approving it
certifies that this regulation will not have a significant economic
impact on a substantial number of small entities. This action
temporarily places AMT and 5-MeO-DIPT into Schedule I of the Controlled
Substances Act.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive order 12988 Civil Justice
Reform.
Executive Order 13132 Federalism
This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132, it is determined that this rule will not have sufficient
federalism implications to warrant the preparation of a Federalism
Assessment.
Unfunded Mandates Reform Act
This rule will not result in the expenditure by State, local and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more in any one year, and it will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under provisions of the Unfunded Mandates Reform Act of 1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by Sec. 804 of the Small
Business Regulatory Enforcement Fairness Act of 1996. This rule will
not result in an annual effect on the economy of $100,000,000 or more;
a major increase in costs or prices; or significant adverse effects on
competition, employment, investment, productivity, innovation, or on
the ability of United States-based
[[Page 16430]]
companies to compete with foreign-based companies in domestic and
export markets.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Narcotics, Prescription drugs, Reporting and Record keeping
requirements.
0
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 28 CFR 0.100, and redelegated to the Deputy Administrator
pursuant to 28 CFR 0.104, the Deputy Administrator hereby amends 21 CFR
part 1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES [Amended]
0
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.
0
2. Section 1308.11 is amended by adding paragraphs (g)(6) and (g)(7) to
read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(g) * * *
(6) Alpha-methyltryptamine (AMT), its isomers, salts and salts of
isomers--7432.
(7) 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT), its isomers,
salts and salts of isomers--7439.
Dated: March 27, 2003.
John B. Brown III,
Deputy Administrator.
[FR Doc. 03-8171 Filed 4-3-03; 8:45 am]
BILLING CODE 4410-09-M