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July 15, 2020 July 15, 2020 Basis for the Recommendation to Control N-ethylpentylone and Its Optical, Geometric, and Positional Isomers, Salts, and Salts of Isomers in Schedule I of the Controlled Substances Act I. SUMMARY On September 25, 2019, the Drug Enforcement Administration (DEA) requested that the Department of Health and Human Services (HHS) conduct a medical and scientific evaluation of N-ethylpentylone (“2019 DEA request to HHS”) to determine whether it should be recommended for control under the Controlled Substances Act (CSA). N- ethylpentylone (also known as ephylone and N-ethylnorpentylone; 1-(1,3-benzodioxol-5- yl)-2-( ethylamino)pentan-1-one) is a synthetic cathinone that functions as a central nervous system (CNS) stimulant (lkeji, 2017). The medical and scientific evaluation of whether a substance should be recommended for control under the CSA is performed for HHS by the Food and Drug Administration (FDA), with the concurrence of the National Institute on Drug Abuse (NIDA) (see the Memorandum of Understanding, 50 FR 9518, 9518-20, Mar. 8, 1985). N-ethylpentylone has no known medical use in the United States, does not have an approved new drug application, and is not currently marketed anywhere in the world as an approved drug product. On August 31, 2018, the DEA published a temporary scheduling order in the Federal Register (83 FR 44474) temporarily placing N-ethylpentylone, as well as its optical, geometric, and positional isomers, salts, and salts of isomers in Schedule I of the CSA upon finding that this action was necessary to avoid an imminent hazard to the public safety. Between 2014 and 2019, U.S. law enforcement agencies encountered N-ethylpentylone in 44 states as well as in the District of Columbia and Puerto Rico, indicating that this drug was available for abuse purposes. Chemically, N-ethylpentylone is structurally related to the Schedule I cathinone stimulants, methylenedioxypyrovalerone (MDPV), methylone, mephedrone, 4-methyl-N- ethylcathinone (4-MEC), 4-methyl-pyrrolidinopropiophenone (4-MePPP), alpha- pyrrolidinopentiophenone (α-PVP), 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1- one (butylone), 2-(methylamino)-1-phenylpentan-1-one (pentedrone), 1-(1,3- benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone), 4-fluoro-N- methylcathinone (4-FMC; flephedrone), 3-fluoro-N- methylcathinone (3-FMC), 1- (naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone), and alpha- pyrrolidinobutiophenone (α-PBP). N-ethylpentylone also elicits pharmacological effects similar to these Schedule I cathinones. N-ethylpentylone CSA Schedule I Recommendation Pursuant to 21 U.S.C. 811(b), the Secretary of HHS is required to consider in a scientific and medical evaluation, eight factors determinative of control under the CSA. These eight factors are the following: 1. Its actual or relative potential for abuse; 2. Scientific evidence of its pharmacological effect, if known; 3. The state of current scientific knowledge regarding the drug or other substance; 4. Its history and current pattern of abuse; 5. The scope, duration, and significance of abuse; 6. What, if any, risk there is to the public health; 7. Its psychic or physiological dependence liability; and 8. Whether the substance is an immediate precursor of a substance already controlled under the CSA. Following consideration of these eight factors, the Secretary must make three findings and a recommendation for scheduling a drug or substance in the CSA. The three findings relate to a substance's abuse potential, legitimate medical use, and safety or dependence potential (see 21 U.S.C. 812(b)). After assessing all the available data, FDA recommends that N-ethylpentylone and its optical, geometric, and positional isomers, salts, and salts of isomers be controlled in Schedule I of the CSA. Schedule I drugs are classified as having a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use of the drug under medical supervision. NIDA concurs with this recommendation. II. EVALUATING N-ETHYLPENTYLONE UNDER THE EIGHT FACTORS This section evaluates the scientific and medical information about N-ethylpentylone under the eight factors that must be considered pursuant to 21 U.S.C. 811(c). Available information that was evaluated included information provided in the 2019 DEA request to HHS, papers published in scientific and medical literature, law enforcement data from seizures and surveillance, and anecdotal reports on the human use of N-ethylpentylone. FACTOR 1. ITS ACTUAL OR RELATIVE POTENTIAL FOR ABUSE The term “abuse” is not defined in the CSA. However, the legislative history of the CSA1 describes the potential for abuse of a particular substance as follows: a. Individuals are taking the substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community. 1 Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970), reprinted in U.S.C.C.A.N. 4566, 4603. 2 N-ethylpentylone CSA Schedule I Recommendation b. There is significant diversion of the drug or substance from legitimate drug channels. c. Individuals are taking the substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such substance. d. The substance is so related in its action to a 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. There is no single test or assessment procedure that, by itself, provides a full and complete characterization of a substance’s abuse potential because this is a complex determination that is multi-dimensional. When assessing the abuse potential of a substance, the Secretary considers multiple factors, data sources, and analyses. These factors include the prevalence, frequency, and manner of use in the general public and specific subpopulations, the amount of material that is available for illicit use, and evidence relevant to populations that may be at particular risk. Animal, human, and epidemiological data are all used in determining a substance’s abuse potential. Specifically, a comprehensive evaluation of the relative abuse potential of a substance includes consideration of available data regarding the drug’s receptor binding affinity, preclinical pharmacology, reinforcing effects, discriminative stimulus effects, dependence-producing potential, pharmacokinetics, routes of administration, and toxicities, as well as an assessment of the clinical efficacy safety database relative to actual abuse, clinical abuse potential studies, and the public health risks following marketing of the substance. Epidemiological data can also be an important indicator of actual abuse. Finally, evidence of clandestine production and illicit trafficking of a substance are also important factors. Below is a discussion of the four indicators of abuse as they relate to N-ethylpentylone. a. Individuals are taking the substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community. Evidence that individuals are taking N-ethylpentylone in amounts sufficient to create a health hazard is found in DEA databases and published medical reports (see Factor 2). N-ethylpentylone has also been seized by law enforcement in the United States (see Factor 5), demonstrating the availability of the substance as a drug of abuse. Thus, N- ethylpentylone presents safety hazards to the health of individuals who consume it. 3 N-ethylpentylone CSA Schedule I Recommendation b. There is significant diversion of the drug or substance from legitimate drug channels. Given that N-ethylpentylone is not an approved drug product in the United States and there are no known legitimate drug channels from which this substance can be diverted, this characteristic of abuse potential is not applicable. c. Individuals are taking the substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such substances. N-ethylpentylone is not an approved drug product in the United States, so a practitioner may not legally prescribe the drug and it cannot be dispensed to an individual. Therefore, individuals who use N-ethylpentylone are doing so without medical advice. N-ethylpentylone is an illicit substance that has been seized by law enforcement. According to the 2019 DEA request to HHS and anecdotal reports (see Factor 2), N- ethylpentylone had pharmacological effects similar to the Schedule I cathinones, pentylone, mephedrone, methylone, and MDPV, as well as to the Schedule II stimulants, cocaine and methamphetamine. Thus, individuals who use N-ethylpentylone are doing so on their own initiative. d. The substance is so related in its action to a 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
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