Since this rule establishes the control status of N-ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8 and 4-chloro-α-PVP, which has been in force for more than two years, it does not change the legal obligations of a person handling these substances. On the contrary, only the current status of the timetable and the corresponding legal obligations are made permanent. Therefore, the DEA makes the rule effective on the date of publication in the Federal Register, as any delay in the effective date is unnecessary and would be contrary to the public interest. See 5 U.S.C. 553(d). The medico-legal autopsy revealed no obvious pathological changes in the organs, with the exception of pulmonary congestion, mild focal pulmonary oedema, brain swelling and congestion, left ventricular hypertrophy and focal fatty liver disease. Compared to cathinone, N-ethylhexedrone consists of two additional substitutions. In the Rα position, the n-butyl substitution forms a hexane chain. The second substitution is an ethyl group that is attached to the amine group to RN2 and thus forms N-ethyl. The toxicity and long-term health effects of recreational use of N-ethylhexedrone do not appear to have been studied in a scientific context and the exact toxic dosage is unknown. This is because N-ethylhexedron has a very short history of human use. • N-ethylhexedron (other names: α-ethylaminohexanophenone, 2-(ethylamino)-1-phenylhexan-1-one), 2.
Security. N-ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are subject to the security requirements of Schedule I and must be handled and stored in accordance with 21 U.S.C. 823 and 21 CFR 1301.71-1301.76. Non-practitioners handling N-ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8 or 4-chloro-α-PVP must also meet the employee selection requirements of 21 CFR 1301.90-1301.93. 1. Registration. Any person handling and handling N-ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-α-PVP must be registered with the DEA to begin printing page 32998 and conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and 21 CFR Parts 1301 and 1312. The Administrator has reviewed this final rule in accordance with the Regulatory Flexibility Act, 5 U.S.C.
601-612, and certifies by its approval that it will not have a significant economic impact on a significant number of small businesses. On July 18, 2019, the DEA issued an order to temporarily include N-ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in Annexes I of the CSA pursuant to the temporary planning provisions of 21 U.S.C. 811(h). 84 EN 34291 DEA believes that all companies handling or planning to handle these substances already have the necessary systems and processes in place and implemented to handle N-ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-α-PVP. There are currently 34 unique registrations specifically authorised to handle N-ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8 or 4-chloro-α-PVP, as well as a number of approved analytical laboratories authorised for the general handling of Annex I controlled substances. Based on the review of entity names, the DEA estimates that these 34 registrations represent 29 entities. Some of these entities are likely to be large entities. However, since the DEA has no information on the size of the registrant and the majority of those enrolled in the DEA are small businesses or employed by small businesses, the DEA estimates that a maximum of 29 companies are small businesses. Therefore, the DEA conservatively estimates that up to 29 small businesses will be affected by this proposed rule. Containing synthetic cathinones, product packaging containing N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8 or 4-chloro-[alpha]-PVP may also contain the warning “not for human consumption”, most likely in order to circumvent legal restrictions on these substances. Law enforcement data indicate that N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8 and 4-chloro-[alpha]-PVP are available and misused for illicit purposes. Demographic data collected from published reports and mortality registers suggest that the primary users of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8 and 4-chloro-[alpha]-PVP, similar to other synthetic List I cathinones permanently listed in Annex I, are young adults.
Toxicological reports have also shown that N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8 and 4-chloro-[alpha]-PVP are ingested with other substances such as other synthetic cathinones, common cutting agents or other recreational substances. Therefore, products containing synthetic cathinones, including N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8 or 4-chloro-[alpha]-PVP, are distributed to users, often with unpredictable results. Therefore, recreational abuse of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8 and 4-chloro-[alpha]-PVP is a significant problem. These data suggest that N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8 and 4-chloro-[alpha]-PVP have a history and a current pattern of abuse. The Administrator commences ex officio proceedings under 21 U.S.C. 811(a)(1) to permanently plan N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP. The DEA collected and reviewed available information on the pharmacology, chemistry, human trafficking, actual abuse, patterns of abuse, and the relative abuse potential of these synthetic cathinones. On October 22, 2020, the acting administrator of the DEA submitted a request to the Assistant Secretary of Health of HHS (Assistant Secretary) to provide the DEA with a scientific and medical evaluation of available information and a temporal recommendation for N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP under 21 U.S.C. 811(b) and (c).
During the evaluation of the scientific and medical evidence on July 8, 2021, the Assistant Secretary submitted the scientific and medical evaluation and planning recommendation for these substances to Acting Administrator HHS. After receiving HHS`s recommendation for scientific and medical assessment and planning, DEA reviewed the document and all other relevant data and conducted its own eight-factor analysis of the abuse potential of N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-[alpha]-PVP as defined in 21 U.S.C. 811 (c). There are very few data on the human pharmacokinetics and pharmacodynamics of N-ethylhexedrone and many other recently introduced substituted cathinones, with the exception of post-mortem results in overdose. [16] [17] [18] Like amphetamines, synthetic cathinones exert their stimulating and sympathomimetic effects by increasing the synaptic concentration of catecholamines such as dopamine, serotonin and norepinephrine. [19] These molecules are able to inhibit monoamine reuptake transporters, which reduces the clearance of neurotransmitters from the synapse.