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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS1

and III of the 1971 Convention, quantities used in the manufacture of exempt preparations; and 4 in regard to each substance in Schedule IIIV 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.
The United States complies with this provision as persons acting outside the legal framework established by the CSA
are subject to administrative, civil, and/
or criminal action.
DEA notes that there are differences between the schedules of substances in the 1971 Convention and the CSA. The CSA has five schedules schedules IV
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. 812b. In contrast, the 1971
Convention has four schedules Schedules IIV 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 Methoxetamine Pursuant to 21 U.S.C. 811b, DEA
gathered the necessary data on methoxetamine and on December 30, 2014, submitted it to the Acting Assistant Secretary for Health of HHS
Acting Assistant Secretary with a request for a scientific and medical evaluation of available information and a scheduling recommendation for methoxetamine. Subsequently, on April 14, 2017, DEA submitted additional data on methoxetamine to the Acting Assistant Secretary. On April 14, 2018, HHS provided to DEA a scientific and medical evaluation entitled Basis for the Recommendation to Place 2-3methoxyphenyl-2-N-ethylaminocyclohexanone Methoxetamine and its Optical Isomers and Salts in Schedule I
of the Controlled Substances Act and a scheduling recommendation.
Following consideration of the eight factors and findings related to the substances abuse potential, legitimate medical use, and dependence liability, HHS recommended that methoxetamine and its optical isomers and salts be
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controlled in schedule I of the CSA
under 21 U.S.C. 812b. In response, DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS and all other relevant data, and completed its own eight-factor review pursuant to 21 U.S.C. 811c. Included below is a brief summary of each factor as analyzed by HHS and DEA in their respective eight-factor analyses, and as considered by DEA in this proposed scheduling determination. Please note that both DEA and HHS analyses are available in their entirety under Supporting Documents of the public docket for this proposed rule at https
www.regulations.gov under docket number DEA568.
1. The Drugs Actual or Relative Potential for Abuse In addition to considering the information HHS provided in its scientific and medical evaluation document for methoxetamine, DEA also considered all other relevant data regarding actual or relative potential for abuse of methoxetamine. The term abuse is not defined in the CSA, however the legislative history of the CSA suggests the following four prongs in determining whether a particular drug or substance has a potential for abuse: 2
a. Individuals are taking the drug or other 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 a significant diversion of the drug or other substance from legitimate drug channels; or c. Individuals are taking the drug or other substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs; or d. The drug is so related in its action to a drug or other substance already listed as having a potential for abuse to make it likely that it will have the same potential for abuse as such substance, 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.
DEA reviewed the scientific and medical evaluation provided by HHS
and all other data relevant to the abuse potential of methoxetamine. These data 2 Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 911444, 91st Cong., 2nd Sess. 1970 reprinted in 1970
U.S.C.C.A.N. 4566, 4603.

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as presented below demonstrate that methoxetamine has a high potential for abuse.
a. There Is Evidence That Individuals Are Taking the Drug or Other Substance in Amounts Sufficient To Create a Hazard to Their Health or to the Safety of Other Individuals or to the Community According to HHS, individuals are taking methoxetamine in amounts sufficient to create a hazard to their health or to the safety of other individuals and to the community.
Published case reports described nonfatal and fatal intoxications from the United States and Europe, including Poland, the United Kingdom, and Switzerland. The 2014 European Monitoring Centre for Drugs and Drug Addiction EMCDDA report on methoxetamine mentioned 20
confirmed by analysis of postmortem biological samples death reports received between 2011 and 2013 from European Union Member States to the Early Warning System. Between 2011
and 2014, scientific publications have reported one death related to methoxetamine from Switzerland, eight deaths from the United Kingdom, and at least two deaths from Poland. In the United States, methoxetamine has been reported as the cause of death in two cases; one case was mentioned in the 2014 Annual Report of the American Association of Poison Control Centers National Poison Data System, and the second case was from a 2013 news report mentioning the Medical Examiners findings from that death.
Additionally, two case reports suggest that some individuals use methoxetamine to self-medicate for some clinical conditions, specifically chronic foot pain and post-traumatic stress disorder. Further, a case report published in 2019 suggests a single injection of methoxetamine can induce prolonged psychosis with confirmed cognitive deficits. As stated by HHS, when abused, methoxetamine can be administered through intranasal insufflation or snorting, oral, sublingual, rectal, intramuscular, and intravenous routes of administration.
Abuse of methoxetamine, similar to PCP
and ketamine abuse, produces dissociative anesthetic and hallucinogenic effects, including somatic and psychological effects such as: Euphoria, increased empathy, sense of dissociation from the body, vivid visual hallucinations, and pleasant intensification of sensory experiences.
Users report in online forums that methoxetamine generally produces longer lasting effects, with a delayed
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