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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules
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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 individuals 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.
2. Scientific Evidence of the Drugs 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 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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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 stimulantlike 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 HHSs 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 drugs 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,
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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 HHSs 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 widespread.
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
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