Criminal liability. Any activity involving methylone that is not authorized under the Controlled Substances Act or the Import and Export of Controlled Substances Act or that contravenes the Controlled Substances Act is illegal. Methamphetamine, cathinone and methcathinone have pharmacological effects on monoamine transporters. In addition, the behavioural effects of methylone in animals and humans were found to be similar to those of Schedule I and Schedule II substances, which have a high potential for abuse. In humans, methylone is expected to elicit subjective reactions similar to those of MDMA, methamphetamine and cocaine, based on studies of drug discrimination in rodents. As a result, published case reports show that methylone produces pharmacological effects, including side effects characteristic of substances such as MDMA, methamphetamine, amphetamine and cocaine. In addition, the misuse of methylone poses a risk to the safety of the individual. Emergency room cases and deaths related to methylone abuse have been reported. In addition, there is currently no accepted medical use for methylone (for the reasons already stated (see factor 3, “The current state of scientific knowledge regarding the drug or other substance”, above)).

Quotas. Quotas for methylone were established on the basis of registrations and quota applications granted under Part 1303 of Title 21 of the Code of Federal Regulations. (3) There is no recognised safety for the use of 3,4-methylenedioxy-N-methylcathinone (methylone) under medical supervision. Purchase Orders. All registrants involved in the distribution of methylone must comply with the requirements of the order form set forth in 21 U.S.C. 828 and 21 CFR 1305. 3. Current scientific knowledge about the drug or other substance: Methylone is a [beta]-cetophenethylamine (i.e., synthetic cathinone) that is structurally and pharmacologically similar to amphetamine, methamphetamine, MDMA, cathinone and other related substances. Methylone can be prepared from its corresponding ketone by a two-step synthesis. Studies show that humans metabolize methylone and that methylone metabolites have been found in urine samples from humans and animals given methylone. Research on antidepressants and antiparkinsonian drugs led to the synthesis and patenting of methylone. However, according to HHS, methylone has no accepted medical use in the United States, does not have an approved NDA, and is not currently marketed in the United States in an FDA-approved drug.

A drug has a “currently accepted medical use” if the following five elements are met: the chemistry of the drug is known and reproducible; and adequate safety studies are in place; and there are adequate and well-controlled studies demonstrating efficacy; and the drug is accepted by qualified experts; And scientific evidence is widely available. 57 FR 10499. HHS also states that there are no published clinical trials with methylone. The DEA also found no evidence of clinical trials on the efficacy and safety of methylone in the scientific and medical literature. Although the chemistry of methylone is known and has been replicated, as mentioned above, there are no clinical studies with methylone. Therefore, methylone currently has no accepted medical use in treatment in the United States and has no accepted safety for the use of methylone under medical supervision. Methylone is the substituted cathinone analogue of MDMA and the 3,4-methylenedioxy analogue of methcathinone. The only structural difference of methylone from MDMA is the substitution of 2 hydrogen atoms by 1 oxygen atom in the β position of the phenethylamine ring, forming a ketone group. [2] Concerns about banning or restricting its use in research: Several commenters stated that listing on Appendix I would create barriers for clinicians or researchers who may be interested in studying the potential benefits of methylone in patients. According to these commentators, listing methylone in Appendix I would be disastrous for research into the use of serotonin-releasing agents to treat anxiety disorders. In addition, commentators have argued that while recent studies have shown that methylone has enormous potential and “efficacy” in terms of post-traumatic stress disorder (PTSD), listing I implicitly “undermines” and “seriously hinders” subsequent research attempts to find medical applications. One commentator also claimed that “methylone, like MDMA, releases serotonin and, to a lesser extent, dopamine and norepinephrine, but releases these chemicals in different proportions than MDMA.” This commenter argued that listing I would somehow undermine efforts to compare the effects of methylone to MDMA by “essentially silencing” such research and “hindering” the progress of better treatments.

Another commentator claimed that listing on List I would “cripple learning efforts,” make research approval “difficult and time-consuming,” and create “stigma” around methylone. This commenter argued that unknown substances such as methylone should be left in a legal status that allows for further research on these substances. 5. Scope, duration and extent of abuse: Evidence of methylone misuse is confirmed by drug treatment courts7 calls to poison control centres and encounters by law enforcement. Methylone has been identified in samples taken from individuals tested by drug treatment court participants. Drug treatment courts have submitted DEA 18 reports detailing the analysis of biological samples containing synthetic cathinones. Methylone was mentioned in 5 of these reports. Evidence from poison control centers also suggests that abuse of synthetic cathinones such as methylone is widespread.