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Federal Register / Vol. 86, No. 134 / Friday, July 16, 2021 / Proposed Rules
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States but there have been reports of individuals experiencing adverse outcomes after taking these substances.
Because these substances are not approved drug products, a practitioner may not legally prescribe them, and they cannot be dispensed to an individual. The use of these substances without medical advice leads to the conclusion that these synthetic cathinones are being abused for their psychoactive properties.
Reports from public health and law enforcement state that these substances are being abused and taken in amounts sufficient to create a hazard to an individuals health. This hazard is evidenced by emergency department admissions or deaths, representing a significant safety issue for those in the community. Further, from January 2012
through December 2020 query date:
May 3, 2021, the National Forensic Laboratory Information System NFLIS
databases registered a total of 2,289
reports by participating DEA, State, local, and other forensic laboratories, as applicable, pertaining to Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP.2
NFLIS registered these reports identifying these substances in drugrelated exhibits from more than 40
States. MPHP was first identified in June 2012 in seized drug evidence although MPHP was identified in blood samples from a 27-year-old decedent in 2011, followed by 4-MEAP and PV8
August and December 2013, respectively, alpha-PHP May 2014, 4chloro-a-PVP December 2015 and most recently N-ethylhexedrone August 2016. Consequently, the data indicate that N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP are being abused, and they present safety hazards to the health of individuals who consume them due to their stimulant properties.
2. Scientific Evidence of the Drugs Pharmacological Effects, if Known: As described by HHS, studies show that Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP
produce pharmacological effects that are similar to those produced by schedule I
and II substances such as methamphetamine II, cocaine II, mephedrone I, MDPV I, and methylone I. Similar to these schedule 2 NFLIS is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by state and local forensic laboratories across the country.
The NFLIS participation rate, defined as the percentage of the national drug caseload represented by laboratories that have joined NFLIS, is over 97 percent. NFLIS includes drug chemistry results from completed analyses only.

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I and II substances, N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP bind to monoamine transporters for dopamine and norepinephrine, and block the uptake of these neurotransmitters at their transporters. N-Ethylhexedrone, a-PHP, and MPHP 4-MEAP, PV8, and 4-chloroa-PVP were not tested in this assay do not promote the release of these monoamines. Additionally, behavioral studies in animals demonstrate that Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP
produce locomotor behavior and discriminative stimulus effects that are similar to those of methamphetamine and cocaine. Overall, these data indicate that N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP
produce pharmacological effects and stimulant-like behaviors that are similar to those of other schedule I synthetic cathinones such as methcathinone, mephedrone, MDPV, and methylone, as well as schedule II stimulants methamphetamine and cocaine.
3. The State of Current Scientific Knowledge Regarding the Drug or Other Substance: N-Ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, and 4-chloro-a-PVP
are designer drugs of the phenethylamine class and they are structurally similar to permanently controlled schedule I synthetic cathinones and schedule II stimulants like methamphetamine.
Pharmacokinetic studies show that humans, in general, metabolize synthetic cathinones to their corresponding amphetamines followed by reduction of the beta-keto group to the corresponding alcohol which can involve hydrogenation, deethylation, demethylation, or hydroxylation. Given that N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP are synthetic cathinones, it is likely that these six synthetic cathinones are also metabolized to their corresponding amphetamines and alcohols.
Neither DEA nor HHS is aware of any currently accepted medical use for Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP.
According to HHSs 2021 scientific and medical evaluation and scheduling recommendation, the Food and Drug Administration FDA has not approved marketing applications for drug products containing N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP for any therapeutic indication, nor is HHS aware of any reports of clinical studies or claims of accepted medical use for Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP in the United States.

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A drug has a currently accepted medical use if 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.3 Based on this analysis, N-ethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-aPVP have no currently accepted medical use in the United States. Furthermore, DEA has not found any references regarding clinical testing of these substances in the scientific and medical literature. Although the chemistry of synthetic cathinones, in general, is known and has been reproduced, as mentioned above there are no clinical studies involving N-ethylhexedrone, aPHP, 4-MEAP, MPHP, PV8, and 4chloro-a-PVP. Taken together with HHSs conclusion, DEA finds that there is no legitimate medical use for Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP in the United States.
4. History and Current Pattern of Abuse: Available evidence suggests that the history and pattern of abuse of Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP
parallel that of permanently controlled schedule I cathinone stimulants. Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP are synthetic cathinones of the phenethylamine class and they are structurally and pharmacologically similar to schedule I and II substances such as methcathinone I and methamphetamine II. Like these schedule I and II substances, Nethylhexedrone, a-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-a-PVP are most likely ingested by swallowing capsules or tablets or snorted by nasal insufflation of the powder tablets. As reported by DEA and HHS, products containing N-ethylhexedrone, a-PHP, 4MEAP, MPHP, PV8, or 4-chloro-a-PVP, similar to schedule I synthetic cathinones, are likely to be falsely marketed as research chemicals, jewelry cleaner, stain remover, plant food or fertilizer, insect repellants, or bath salts; sold at smoke shops, head shops, convenience stores, adult book stores, or gas stations;
and purchased on the internet. Like those seen with commercial products 3 57 FR 10499 1992, pet. for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 D.C. Cir. 1994.

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