Proposed Rule2021-18843
Schedules of Controlled Substances: Placement of Methiopropamine in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 2, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration proposes placing N-methyl- 1-(thiophen-2-yl)propan-2-amine (methiopropamine), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle methiopropamine.
Full Text
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<title>Federal Register, Volume 86 Issue 168 (Thursday, September 2, 2021)</title>
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[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Proposed Rules]
[Pages 49267-49273]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18843]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-737]
Schedules of Controlled Substances: Placement of Methiopropamine
in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration proposes placing N-methyl-
1-(thiophen-2-yl)propan-2-amine (methiopropamine), including its salts,
isomers, and salts of isomers, in schedule I of the Controlled
Substances Act. This action is being taken to enable the United States
to meet its obligations under the 1971 Convention on Psychotropic
Substances. If finalized, this action would impose the regulatory
controls and administrative, civil, and criminal sanctions applicable
to schedule I controlled substances on persons who handle (manufacture,
distribute, reverse distribute, import, export, engage in research,
conduct instructional activities or chemical analysis, or possess) or
propose to handle methiopropamine.
DATES: Comments must be submitted electronically or postmarked on or
before October 4, 2021.
Interested persons may file written comments on this proposal in
accordance with 21 CFR 1308.43(g). Commenters should be aware that the
electronic Federal Docket Management System will not accept comments
after 11:59 p.m. Eastern Time on the last day of the comment period.
Interested persons may file a request for a hearing or waiver of
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR
1316.45 and/or 1316.47, as applicable. Requests for a hearing and
waivers of an opportunity for a hearing or to participate in a hearing,
together with a written statement of position on the matters of
[[Page 49268]]
fact and law asserted in the hearing, must be received on or before
October 4, 2021.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-737'' on all electronic and written correspondence,
including any attachments.
<bullet> Electronic comments: The Drug Enforcement Administration
(DEA) encourages that all comments be submitted electronically through
the Federal eRulemaking Portal which provides the ability to type short
comments directly into the comment field on the web page or attach a
file for lengthier comments. Please go to <a href="http://www.regulations.gov">http://www.regulations.gov</a>
and follow the online instructions at that site for submitting
comments. Upon completion of your submission, you will receive a
Comment Tracking Number for your comment. Please be aware that
submitted comments are not instantaneously available for public view on
<a href="http://Regulations.gov">Regulations.gov</a>. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
<bullet> Paper comments: Paper comments that duplicate the
electronic submission are not necessary. Should you wish to mail a
paper comment, in lieu of an electronic comment, it should be sent via
regular or express mail to: Drug Enforcement Administration, Attn: DEA
Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
<bullet> Hearing requests: All requests for a hearing and waivers
of participation, together with a written statement of position on the
matters of fact and law asserted in the hearing, must be sent to: Drug
Enforcement Administration, Attn: Administrator, 8701 Morrissette
Drive, Springfield, Virginia 22152. All requests for hearing and
waivers of participation should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. The Drug Enforcement
Administration (DEA) will make them available, unless reasonable cause
is given, for public inspection online at <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Such information includes personal identifying information (such as
your name, address, etc.) voluntarily submitted by the commenter. The
Freedom of Information Act applies to all comments received. If you
want to submit personal identifying information (such as your name,
address, etc.) as part of your comment, but do not want it to be made
publicly available, you must include the phrase ``PERSONAL IDENTIFYING
INFORMATION'' in the first paragraph of your comment. You must also
place all of the personal identifying information you do not want made
publicly available in the first paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
DEA will make available publicly in redacted form comments
containing personal identifying information or confidential business
information identified as directed above. If a comment has so much
confidential business information that it cannot be redacted
effectively, all or part of that comment may not be made available
publicly. Comments posted to <a href="http://www.regulations.gov">http://www.regulations.gov</a> may include any
personal identifying information (such as name, address, and phone
number) included in the text of your electronic submission that is not
identified, as directed above, as confidential as directed above.
An electronic copy of this document and supplemental information to
this proposed rule are available at <a href="http://www.regulations.gov">http://www.regulations.gov</a> for easy
reference.
Request for Hearing or Appearance; Waiver
Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act, 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D. Interested persons may file requests for hearing or notices
of intent to participate in a hearing in conformity with the
requirements of 21 CFR 1308.44(a) or (b), and include a statement of
interest in the proceeding and the objections or issues, if any,
concerning which the person desires to be heard. 21 CFR 1316.47(a). Any
interested person may file a waiver of an opportunity for a hearing or
to participate in a hearing together with a written statement regarding
the interested person's position on the matters of fact and law
involved in any hearing as set forth in 21 CFR 1308.44(c).
All requests for a hearing and waivers of participation, together
with a written statement of position on the matters of fact and law
asserted in the hearing, must be sent to DEA using the address
information provided above.
Legal Authority
The United States is a party to the 1971 United Nations Convention
on Psychotropic Substances (1971 Convention), February 21, 1971, 32
U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting
changes in drug schedules under the 1971 Convention are governed
domestically by 21 U.S.C. 811(d)(2-4). When the United States receives
notification of a scheduling decision pursuant to Article 2 of the 1971
Convention adding a drug or other substance to a specific schedule, the
Secretary of the Department of Health and Human Services (HHS),\1\
after consultation with the Attorney General, shall first determine
whether existing legal controls under subchapter I of the Controlled
Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act meet
the requirements of the schedule specified in the notification with
respect to the specific drug or substance. 21 U.S.C. 811(d)(3). In the
event that the Secretary of HHS (Secretary) did not consult with the
Attorney General, and the Attorney General did not issue a temporary
order, as provided under 21 U.S.C. 811(d)(4), the procedures for
permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control.
Pursuant to 21 U.S.C. 811(a)(1), the Attorney General, by rule, may add
to such a schedule any drug or other substance, if he finds that such
drug or other substance has a potential
[[Page 49269]]
for abuse, and makes with respect to such drug or other substance the
findings prescribed by 21 U.S.C. 812(b) for the schedule in which such
drug is to be placed. The Attorney General has delegated this
scheduling authority to the Administrator of DEA. 28 CFR 0.100.
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\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in
carrying out the Secretary's scheduling responsibilities under the
Controlled Substances Act, with the concurrence of NIDA. 50 FR 9518
(March 8, 1985). The Secretary of HHS has delegated to the Assistant
Secretary for Health of HHS the authority to make domestic drug
scheduling recommendations. 58 FR 35460 (July 1, 1993).
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Background
Methiopropamine is a central nervous stimulant and is structurally
related to the schedule II stimulants methamphetamine and amphetamine.
On April 21, 2017, the Secretary-General of the United Nations advised
the Secretary of State of the United States that during its 60th
session, on March 16, 2017, the Commission on Narcotic Drugs voted to
place N-methyl-1-(thiophen-2-yl)propan-2-amine (methiopropamine) in
Schedule II of the 1971 Convention (CND Dec/60/8). Because the
procedures in 21 U.S.C. 811(d)(3) and (4) for consultation and issuance
of a temporary order for methiopropamine, discussed in the above legal
authority section, were not followed, DEA is utilizing the procedures
for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) to
control methiopropamine. Such scheduling would satisfy the United
States' international obligations.
Article 2, paragraph 7(b), of the 1971 Convention sets forth the
minimum requirements that the United States must meet when a substance
has been added to Schedule II of the 1971 Convention. Pursuant to the
1971 Convention, the United States must require licenses for the
manufacture, export and import, and distribution of methiopropamine.
This license requirement is accomplished by the CSA's registration
requirement as set forth in 21 U.S.C. 822, 823, 957, 958 and in
accordance with 21 CFR parts 1301 and 1312. In addition, the United
States must adhere to specific export and import provisions set forth
in the 1971 Convention. This requirement is accomplished by the CSA's
export and import provisions established in 21 U.S.C. 952, 953, 957,
958 and in accordance with 21 CFR part 1312. Likewise, under Article
13, paragraphs 1 and 2, of the 1971 Convention, a party to the 1971
Convention may notify through the UN Secretary-General another party
that it prohibits the importation of a substance in Schedule II, III,
or IV of the 1971 Convention. If such notice is presented to the United
States, the United States shall take measures to ensure that the named
substance is not exported to the notifying country. This requirement is
also accomplished by the CSA's export provisions mentioned above. Under
Article 16, paragraph 4, of the 1971 Convention, the United States is
required to provide annual statistical reports to the International
Narcotics Control Board (INCB). Using INCB Form P, the United States
shall provide the following information: (1) In regard to each
substance in Schedule I and II of the 1971 Convention, quantities
manufactured in, exported to, and imported from each country or region
as well as stocks held by manufacturers; (2) in regard to each
substance in Schedule II and III of the 1971 Convention, quantities
used in the manufacture of exempt preparations; and (3) in regard to
each substance in Schedule II-IV of the 1971 Convention, quantities
used for the manufacture of non-psychotropic substances or products.
Lastly, under Article 2 of the 1971 Convention, the United States must
adopt measures in accordance with Article 22 to address violations of
any statutes or regulations that are adopted pursuant to its
obligations under the 1971 Convention. Persons acting outside the legal
framework established by the CSA are subject to administrative, civil,
and/or criminal action; therefore, the United States complies with this
provision.
DEA notes that there are differences between the schedules of
substances in the 1971 Convention and the CSA. The CSA has five
schedules (schedules I-V) with specific criteria set forth for each
schedule. Schedule I is the only possible schedule in which a drug or
other substance may be placed if it has high potential for abuse and no
currently accepted medical use in treatment in the United States. See
21 U.S.C. 812(b). In contrast, the 1971 Convention has four schedules
(Schedules I-IV) but does not have specific criteria for each schedule.
The 1971 Convention simply defines its four schedules, in Article 1, to
mean the correspondingly numbered lists of psychotropic substances
annexed to the Convention, and altered in accordance with Article 2.
Proposed Determination To Schedule Methiopropamine
On November 20, 2018, DEA requested HHS conduct a scientific and
medical evaluation and recommend whether methiopropamine should be
controlled under the CSA. On August 27, 2020 (dated August 25, 2020),
HHS provided DEA a scientific and medical evaluation entitled ``Basis
for the recommendation to control methiopropamine and its salts in
schedule I of the Controlled Substance Act'' and a scheduling
recommendation. Pursuant to 21 U.S.C. 811(b), following consideration
of the eight-factors and findings related to the substance's abuse
potential, legitimate medical use, safety, and dependence liability,
HHS recommended that methiopropamine be controlled in schedule I of the
CSA under 21 U.S.C. 812(b). Upon receipt of the scientific and medical
evaluation and scheduling recommendation from HHS, DEA reviewed the
documents and all other relevant data and conducted its own eight-
factor analysis in accordance with 21 U.S.C. 811(c). Included below is
a brief summary of each factor as analyzed by HHS and DEA, and as
considered by DEA in its proposed scheduling action. Please note that
both DEA and HHS eight-factor analyses are available in their entirety
under the tab ``Supporting Documents'' of the public docket of this
rulemaking action at <a href="http://www.regulations.gov">http://www.regulations.gov</a>, under docket number
``DEA-737.''
1. The Drug's Actual or Relative Potential for Abuse: The term
``abuse'' is not defined in the CSA. However, the legislative history
of the CSA suggests that DEA consider the following criteria when
determining whether a particular drug or substance has a potential for
abuse: \2\
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\2\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970
U.S.C.C.A.N. 4566, 4603.
(a) There is evidence that individuals are taking the drug or
drugs containing such a substance in amounts sufficient to create a
hazard to their health or to the safety of other individuals or to
the community; or
(b) There is significant diversion of the drug or drugs
containing such a substance from legitimate drug channels; or
(c) Individuals are taking the drug or drugs containing such a
substance on their own initiative rather than on the basis of
medical advice from a practitioner licensed by law to administer
such drugs in the course of his professional practice; or
(d) The drug or drugs containing such a substance are new drugs
so related in their action to a drug or drugs already listed as
having a potential for abuse to make it likely that the drug will
have the same potentiality for abuse as such drugs, thus making it
reasonable to assume that there may be significant diversions from
legitimate channels, significant use contrary to or without medical
advice, or that it has a substantial capability of creating hazards
to the health of the user or to the safety of the community.
Both DEA and HHS eight-factor analyses found that methiopropamine
has abuse potential associated with its abilities to produce
psychoactive effects that are similar to those produced by schedule II
stimulants such as amphetamine and methamphetamine
[[Page 49270]]
that have a high potential for abuse. In particular, the responses in
humans to methiopropamine are stimulant-like and include tachycardia,
anxiety, insomnia, perspiration, and hallucination.
Methiopropamine has no approved medical uses in the United States.
Because this substance is not an approved drug product, a practitioner
may not legally prescribe it, and it cannot be dispensed to an
individual. The use of this substance without medical advice leads to
the conclusion that this stimulant is being abused for its psychoactive
properties.
Reports from public health and law enforcement suggest that this
substance is being abused and taken in amounts sufficient to create a
hazard to an individual's health. This hazard is evidenced by deaths,
representing a safety issue for those in the community. Further,
methiopropamine was first identified in the National Forensic
Laboratory Information System (NFLIS) \3\ database in 2011; a September
29, 2020 query of this database for methiopropamine reports indicated a
total of 128 such reports through 2018 from 19 states by participating
federal, state, and local forensic laboratories. Consequently, the data
indicate that methiopropamine is being abused, and it presents safety
hazards to the health of individuals who consume it due to its
stimulant properties, making it a hazard to the safety of the
community.
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\3\ NFLIS represents an important resource in monitoring illicit
drug trafficking, including the diversion of legally manufactured
pharmaceuticals into illegal markets. NFLIS is a comprehensive
information system that includes data from forensic laboratories
that handle more than 96% of an estimated 1.0 million distinct
annual State and local drug analysis cases. NFLIS includes drug
chemistry results from completed analyses only. While NFLIS data is
not direct evidence of abuse, it can lead to an inference that a
drug has been diverted and abused. See 76 FR 77330, 77332, Dec. 12,
2011.
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2. Scientific Evidence of the Drug's Pharmacological Effects, if
Known: As described by HHS, studies show that methiopropamine produces
pharmacological effects that are similar to those produced by schedule
II substances such as amphetamine and methamphetamine. Similar to these
schedule II substances, methiopropamine binds to monoamine transporters
for dopamine and norepinephrine and blocks the uptake of these
neurotransmitters at their transporters. However, methiopropamine does
not have an affinity for serotonin transporters or a significant effect
on serotonin transporter activity. Behavioral studies in animals
demonstrate that methiopropamine produces locomotor behavior similar to
those of amphetamine and methamphetamine. Self-reports by
methiopropamine users demonstrate that methiopropamine produces classic
stimulant-like effects, including euphoria, psychological and
psychomotor stimulation, insomnia, anxiety, panic attacks, and an
increased heart rate. Overall, these data indicate that methiopropamine
produces pharmacological effects and stimulant-like behaviors that are
similar to those of schedule II substances amphetamine and
methamphetamine.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance: Methiopropamine is structurally similar to the
schedule II substances methamphetamine and amphetamine. Specifically,
methiopropamine is a thiophene analog of methamphetamine.
Self-reports by methiopropamine users in 2020 suggest that the
pharmacokinetics of the drug following insufflation are rapid, with the
onset of effects occurring five to ten minutes after administration.
Methiopropamine reaches its maximum concentration at approximately
thirty to sixty minutes later, with a duration of action that can
persist for two to four hours. Limited studies identify nor-
methiopropamine as the main metabolite found in bodily fluids.
Neither DEA nor HHS is aware of any currently accepted medical use
for methiopropamine. According to HHS's August 2020 scientific and
medical evaluation and scheduling recommendation, the Food and Drug
Administration (FDA) has not approved a marketing application for a
drug product containing methiopropamine for any therapeutic indication,
nor is HHS aware of any reports of clinical studies or claims of an
accepted medical use for methiopropamine in the United States.
Although no evidence suggests that methiopropamine has a currently
accepted medical use in treatment in the United States, it bears noting
that a drug cannot be found to have such medical use unless DEA
concludes that it satisfies a five-part test. Specifically, with
respect to a drug that has not been approved by FDA, all of the
following must be demonstrated: The drug's chemistry is known and
reproducible; there are adequate safety studies; there are adequate and
well-controlled studies proving efficacy; the drug is accepted by
qualified experts; and the scientific evidence is widely available. 57
FR 10499 (1992), pet. for rev. denied, Alliance for Cannabis
Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994). Based on this
analysis, methiopropamine has no currently accepted medical use in the
United States. Furthermore, DEA has not found any references regarding
clinical testing of methiopropamine in the scientific and medical
literature. Taken together with HHS's conclusion, DEA finds that there
is no legitimate medical use for methiopropamine in the United States.
4. History and Current Pattern of Abuse: As described by DEA and
HHS, methiopropamine is a stimulant and is structurally and
pharmacologically similar to the schedule II substances methamphetamine
and amphetamine. Methiopropamine has been trafficked and abused in
North America and Europe since its first report of abuse in 2011. In
addition, methiopropamine has been identified in law enforcement
seizures in the United States since 2011 through 2018. Thus,
methiopropamine abuse occurs worldwide.
5. Scope, Duration and Significance of Abuse: Forensic laboratories
have confirmed the presence of methiopropamine in drug exhibits
received from state, local, and federal law enforcement agencies. Law
enforcement data show that methiopropamine first appeared in the
illicit drug market in 2011 with four encounters. Overall, from 2011
through 2018, NFLIS registered 128 reports from federal, state and
local forensic laboratories identifying this substance in drug-related
exhibits from 19 states. Thus, methiopropamine abuse is wide-spread.
6. What, if Any, Risk There Is to the Public Health: Based on the
review of both HHS and DEA, public health risks of methiopropamine
result from its ability to induce stimulant-like responses, which may
lead to adverse events that include psychological and cognitive
impairment. In addition, methiopropamine has been involved, with one or
more other substances, in 14 deaths in the United Kingdom from 2012 to
2016, with methiopropamine being the sole contributing substance in one
death in Australia in 2015. Thus, the public health risks associated
with methiopropamine are confirmed by the pharmacological profile along
with the fatalities associated with methiopropamine.
7. Its Psychic or Physiological Dependence Liability: According to
HHS, the psychic or physiological dependence liability of
methiopropamine is demonstrated by its positive abuse-related studies
in animals and reported stimulant effects in humans. The results from
two behavioral locomotor studies in 2016 demonstrate that
methiopropamine produced behavioral effects similar to
[[Page 49271]]
those of substances with stimulant effects such as amphetamine and
methamphetamine. Furthermore, according to self-reports of drug users
in 2020, methiopropamine has been abused for its stimulant properties.
In addition, DEA notes that because methiopropamine shares
pharmacological properties with schedule II stimulant substances such
as amphetamine and methamphetamine, methiopropamine likely has a
dependence profile similar to these substances, which are known to
cause substance dependence.
In summary, data suggests that methiopropamine produces behavioral
effects in animals and humans similar to those of schedule II
stimulants. Although there are no clinical studies evaluating
dependence liabilities specific for methiopropamine, the
pharmacological profile of this substance suggests that it possesses
dependence liabilities qualitatively similar to schedule II substances
such as amphetamine and methamphetamine.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA: Methiopropamine is not an immediate
precursor of any controlled substance under the CSA as defined by 21
U.S.C 802(23).
Conclusion: After considering the scientific and medical evaluation
conducted by HHS, HHS's scheduling recommendation, and DEA's own eight-
factor analysis, DEA finds that the facts and all relevant data
constitute substantial evidence of the potential for abuse of
methiopropamine. As such, DEA hereby proposes to permanently schedule
methiopropamine as a schedule I controlled substance under the CSA.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the Assistant Secretary for Health of HHS and review
of all other available data, the Administrator, pursuant to 21 U.S.C.
811(a) and 812(b)(1), finds that:
1. Methiopropamine Has a High Potential for Abuse
Methiopropamine, similar to the schedule II stimulants amphetamine
and methamphetamine, is a stimulant with a high potential for abuse. In
animals, behavioral locomotor studies show that methiopropamine
produces stimulation similar to that of methamphetamine. As HHS
mentions, methiopropamine abuse in humans has been reported in at least
16 countries, including North America and Europe. Additionally, typical
stimulant effects such as euphoria, psychomotor stimulation, and
anxiety have been described from self-reports of methiopropamine
abusers. These effects are similar to those of schedule II stimulant
such as methamphetamine and amphetamine. These data collectively
indicate that methiopropamine has a high potential for abuse similar to
other substances in schedule II such as amphetamine and
methamphetamine.
2. Methiopropamine Currently Has No Accepted Medical Use in Treatment
in the United States
According to HHS, FDA has not approved a marketing application for
a drug product containing methiopropamine for any therapeutic
indication. As HHS states, there are also no clinical studies or
petitioners that claim an accepted medical use in the United States. In
addition, as discussed above in the Factor 3 analysis, methiopropamine
does not satisfy DEA's five-part test for having a currently accepted
medical use in treatment in the United States.
3. There Is a Lack of Accepted Safety for Use of Methiopropamine Under
Medical Supervision
Currently, methiopropamine does not have an accepted medical use as
noted by HHS. Because methiopropamine has no approved medical use in
treatment in the United States and has not been investigated as a new
drug, its safety for use under medical supervision has not been
determined. Thus, there is a lack of accepted safety for use of
methiopropamine under medical supervision.
Although the first finding shows methiopropamine to have similar
effects to schedule II substances such as amphetamine and
methamphetamine, it bears reiterating that there is only one possible
schedule in the CSA--schedule I--to place methiopropamine since it has
no currently accepted medical use in treatment in the United States.
See the background section for additional discussion.
Based on these findings, the Administrator concludes that
methiopropamine (chemical name: N-methyl-1-(thiophen-2-yl)propan-2-
amine), including its salts, isomers, and salts of isomers, warrants
control in schedule I of the CSA. 21 U.S.C. 812(b)(1). More precisely,
because of its stimulant-like effects, DEA is proposing to place
methiopropamine in 21 CFR 1308.11(f) (the stimulants category of
schedule I). As such, the proposed control of methiopropamine includes
the substance as well as its salts, isomers, and salts of isomers.
Requirements for Handling Methiopropamine
If this rule is finalized as proposed, methiopropamine would become
subject to the CSA's schedule I regulatory controls and administrative,
civil, and criminal sanctions applicable to the manufacture,
distribution, reverse distribution, importation, exportation,
engagement in research, and conduct of instructional activities or
chemical analysis with, and possession of schedule I controlled
substances, including the following (as of the effective date of the
planned final scheduling action):
1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, imports, exports, engages in research, or conducts
instructional activities or chemical analysis with, or possesses)
methiopropamine, or who desires to handle methiopropamine, is required
to be registered with DEA to conduct such activities pursuant to 21
U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301
and 1312 as of the effective date of a final scheduling action. Any
person who currently handles methiopropamine, and is not registered
with DEA, would need to submit an application for registration and may
not continue to handle methiopropamine as of the effective date of a
final scheduling action, unless DEA has approved that application for
registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in
accordance with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration would be required to surrender
all quantities of currently held methiopropamine or to transfer all
quantities of currently held methiopropamine to a person registered
with DEA before the effective date of a final scheduling action, in
accordance with all applicable Federal, State, local, and tribal laws.
As of the effective date of a final scheduling action, methiopropamine
would be required to be disposed of in accordance with 21 CFR part
1317, in addition to all other applicable Federal, State, local, and
tribal laws.
3. Security. Methiopropamine would be subject to schedule I
security requirements and would need to be
[[Page 49272]]
handled and stored pursuant to 21 U.S.C. 821, 823, 871(b) and in
accordance with 21 CFR 1301.71-1301.93 as of the effective date of a
final scheduling action. Non-practitioners handling methiopropamine
would also need to comply with the employee screening requirements of
21 CFR 1301.90-1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of methiopropamine would need to be in compliance
with 21 U.S.C. 825 and 958(e) and be in accordance with 21 CFR part
1302 as of the effective date of a final scheduling action.
5. Quota. Only registered manufacturers would be permitted to
manufacture methiopropamine in accordance with a quota assigned
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of
the effective date of a final scheduling action.
6. Inventory. Every DEA registrant who possesses any quantity of
methiopropamine on the effective date of a final scheduling action
would be required to take an inventory of methiopropamine on hand at
that time, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11(a) and (d).
Any person who becomes registered with DEA to handle
methiopropamine on or after the effective date of a final scheduling
action would be required to have an initial inventory of all stocks of
controlled substances (including methiopropamine) on hand on the date
the registrant first engages in the handling of controlled substances
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including methiopropamine) on
hand every two years, pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant would be required to
maintain records and submit reports with respect to methiopropamine
pursuant to 21 U.S.C. 827 and 958(e) and in accordance with 21 CFR
parts 1304 and 1312, as of the effective date of a final scheduling
action. Manufacturers and distributors would be required to submit
reports regarding methiopropamine to the Automation of Reports and
Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance
with 21 CFR parts 1304 and 1312, as of the effective date of a final
scheduling action.
8. Order Forms. Every DEA registrant who distributes
methiopropamine would be required to comply with the order form
requirements, pursuant to 21 U.S.C. 828 and in accordance with 21 CFR
part 1305, as of the effective date of a final scheduling action.
9. Importation and Exportation. All importation and exportation of
methiopropamine would need to be in compliance with 21 U.S.C. 952, 953,
957, and 958, and in accordance with 21 CFR part 1312, as of the
effective date of a final scheduling action.
10. Liability. Any activity involving methiopropamine not
authorized by, or in violation of, the CSA or its implementing
regulations would be unlawful, and may subject the person to
administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a), this proposed scheduling
action is subject to formal rulemaking procedures performed ``on the
record after opportunity for a hearing,'' which are conducted pursuant
to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the
criteria for scheduling a drug or other substance. Such actions are
exempt from review by the Office of Management and Budget (OMB)
pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the
principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth
in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed rule does not
have substantial direct effects on the States, on the relationship
between the national government and the States, or the distribution of
power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-602, has reviewed this proposed rule and by approving
it certifies that it will not have a significant economic impact on a
substantial number of small entities.
DEA proposes placing the substance methiopropamine (chemical name:
N-methyl-1-(thiophen-2-yl)propan-2-amine), including its salts,
isomers, and salts of isomers, in schedule I of the CSA. This action is
being taken to enable the United States to meet its obligations under
the 1971 Convention on Psychotropic Substances. If finalized, this
action would impose the regulatory controls and administrative, civil,
and criminal sanctions applicable to schedule I controlled substances
on persons who handle (manufacture, distribute, reverse distribute,
import, export, engage in research, conduct instructional activities or
chemical analysis with, or possess), or propose to handle,
methiopropamine.
According to HHS, methiopropamine has a high potential for abuse,
has no currently accepted medical use in treatment in the United
States, and lacks accepted safety for use under medical supervision.
DEA's research confirms that there is no legitimate commercial market
for methiopropamine in the United States. Therefore, DEA estimates that
no United States entity currently handles methiopropamine and does not
expect any United States entity to handle methiopropamine in the
foreseeable future. DEA concludes that no legitimate United States
entity would be affected by this rule if finalized. As such, the
proposed rule will not have a significant effect on a substantial
number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies that this
action would not result in any Federal mandate that may result ``in the
expenditure by State, local, and tribal
[[Page 49273]]
governments, in the aggregate, or by the private sector, of $100
million or more (adjusted annually for inflation) in any 1 year * *
*.'' Therefore, neither a Small Government Agency Plan nor any other
action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information under
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA proposes to further amend 21 CFR
part 1308, which we proposed to amend on August 11, 2021 at 86 FR
43983, as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. Amend Sec. 1308.11 by redesignating paragraph (f)(9) through
(f)(11) as (f)(10) through (f)(12) and adding new paragraph (f)(9) to
read as follows:
Sec. 1308.1 Schedule I.
* * * * *
(f) * * *
(9) Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2-amine).. 1478
* * * * *
Anne Milgram,
Administrator.
[FR Doc. 2021-18843 Filed 9-1-21; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on September 2, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.