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Federal Register / Vol. 86, No. 232 / Tuesday, December 7, 2021 / Proposed Rules
deaths in which methoxetamine was implicated in Europe. In the United States, there have been at least two documented deaths associated with the use of methoxetamine, one occurring in 2012 and the other in 2014.

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5. The Scope, Duration, and Significance of Abuse In the United States, evidence of abuse of methoxetamine initially appeared in mid-2011 when a case study was published regarding an individual who was brought to the emergency department following methoxetamine intoxication in Massachusetts. The first reported death in the United States from methoxetamine abuse occurred in Milwaukee County, Wisconsin, in May 2012.
Data from the System to Retrieve Information on Drug Evidence STRIDE
and STARLiMS 3 and the National Forensic Laboratory Information System NFLIS 4 indicate that methoxetamine was found in samples starting in August 2004, in California. Specifically, there were 114 STRIDE/STARLIMS reports from August 2004 through July 2021, and 677 NFLIS reports from January 2011 to July 2021. Combining drug reports and exhibits from both NFLIS
and STRIDE between August 2004 and July 2021, methoxetamine has been encountered in 45 states and the District of Columbia. Methoxetamine drug quantities seized by United States Customs and Border Protection CBP
have ranged from 2 to 200 grams.
Reportedly, a small percentage of the methoxetamine reports from CBP were in combination with other drugs, such as synthetic cannabinoids, synthetic cathinones, ketamine, caffeine, and sildenafil.
In response to abuse and safety concerns, methoxetamine has been controlled in Virginia, Minnesota, North Dakota, Florida, Ohio, Indiana, Louisiana, Alabama, Arizona, and Utah.
Abuse of methoxetamine has been characterized as causing acute public health and safety issues worldwide.
Methoxetamine is now controlled in Russia, Switzerland, Israel, Sweden, 3 STARLiMS is a web-based, commercial laboratory information management system that systematically collects results from drug chemistry analyses conducted by DEA laboratories. On October 1, 2014, STARLiMS replaced STRIDE as DEAs laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014 are reposited in STARLiMS.
STRIDE/STARLiMS data were queried on August 18, 2021.
4 NFLIS is a national forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by state and local forensic laboratories in the United States. NFLIS
data were queried on August 18, 2021.

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United Kingdom, Japan, Germany, France, Brazil, China, Poland and the European Union member states. On September 25, 2014, the European Union council decided to control methoxetamine in all European member states, and on March 18, 2016, the CND, at its 59th Session, added methoxetamine to Schedule II of the 1971 Convention.
6. What, if Any, Risk There Is to the Public Health Methoxetamine shares similar mechanisms of action with and produces similar physiological and subjective effects see Factor 2 for more information as other controlled arylcyclohexylamines, such as the ethylamine analog of phencyclidine PCE; schedule I, the thiophene analog of phencyclidine TCP; schedule I, phencyclidine PCP; schedule II, and ketamine schedule III. Thus, methoxetamine poses the same risks to public health as PCE, TCP, PCP, and ketamine. Predominantly, the risks to public health are centralized to risks of the user, but in some cases do affect the general public, as is the case of driving under the influence.
Users of methoxetamine describe the drug effects as being similar to those of PCP and ketamine. Effects often include hallucinations and dissociation of the physical body, and can produce antidepressant-like effects. Online reports of use of methoxetamine suggest it is used via all routes of administration i.e., intranasal, oral, intramuscular, rectal, and intravenous. Due to the various routes of administration, the onset of effects can vary widely one minute for intravenous to 90 minutes intranasal.
As HHS notes, several case reports pertaining to methoxetamine use, toxicities, and fatal intoxications have been published in the scientific and medical literature in several countries.
In particular, in 2014 EMCDDA reported that methoxetamine was mentioned in 20 biologically confirmed death reports from the European Union member states Early Warning System. At least one published death related to methoxetamine has occurred in Switzerland, eight deaths in the United Kingdom, two deaths in Poland, and two deaths in the United States. In 2015, WHO indicated that a total of 120
nonfatal intoxications and 22 deaths related to methoxetamine had been reported, in which many but not all had been biologically confirmed. Two case reports suggest some individuals use methoxetamine to self-medicate to treat various clinical conditions, specifically chronic foot pain and post-traumatic
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stress disorder. In addition, DEA further notes one case report published in 2019
suggests methoxetamine can induce prolonged psychosis after a single injection.
7. Its Psychic or Physiological Dependence Liability Psychological and physiological dependence are associated with methoxetamine. The euphoric and hallucinogenic effects associated with methoxetamine and other arylcyclohexylamine drugs serve as reinforcers and can result in psychological dependence and are supported by case studies with methoxetamine abusers. Several preclinical studies and case reports examined and described physical dependence and withdrawal effects associated with methoxetamine abuse.
Signs of methoxetamine withdrawal have included low mood and/or depressive thoughts, cognitive impairment lasting several hours followed by two days of insomnia after last use, and a reported suicide attempt.
8. Whether the Substance Is an Immediate Precursor of a Substance Already Controlled Under the CSA
DEA and HHS find that methoxetamine is not an immediate precursor of any controlled substance of the CSA.
Conclusion Based on consideration of the scientific and medical evaluation and accompanying recommendation of HHS, and on DEAs consideration of its own eight-factor analysis, DEA finds that these facts and all relevant data constitute substantial evidence of potential for abuse of methoxetamine.
As such, DEA hereby proposes to schedule methoxetamine as a 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. 812b.
After consideration of the analysis and recommendation of the Acting Assistant Secretary for Health of HHS and review of all other available data, the Administrator of DEA, pursuant to 21
U.S.C. 812b1, finds that:
1 Methoxetamine has a high potential for abuse that is comparable to other scheduled substances such as the ethylamine analog of phencyclidine PCE; schedule I, the thiophene analog
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