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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Proposed Rules
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those of substances with stimulant effects such as amphetamine and methamphetamine. Furthermore, according to self-reports of drug users in 2020, methiopropamine has been abused for its stimulant properties. In addition, DEA notes that because methiopropamine shares pharmacological properties with schedule II stimulant substances such as amphetamine and methamphetamine, methiopropamine likely has a dependence profile similar to these substances, which are known to cause substance dependence.
In summary, data suggests that methiopropamine produces behavioral effects in animals and humans similar to those of schedule II stimulants.
Although there are no clinical studies evaluating dependence liabilities specific for methiopropamine, the pharmacological profile of this substance suggests that it possesses dependence liabilities qualitatively similar to schedule II substances such as amphetamine and methamphetamine.
8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled Under the CSA:
Methiopropamine is not an immediate precursor of any controlled substance under the CSA as defined by 21 U.S.C
80223.
Conclusion: After considering the scientific and medical evaluation conducted by HHS, HHSs scheduling recommendation, and DEAs own eightfactor analysis, DEA finds that the facts and all relevant data constitute substantial evidence of the potential for abuse of methiopropamine. As such, DEA hereby proposes to permanently schedule methiopropamine as a schedule I controlled substance under the CSA.
Proposed Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA
also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812b.
After consideration of the analysis and recommendation of the Assistant Secretary for Health of HHS and review of all other available data, the Administrator, pursuant to 21 U.S.C.
811a and 812b1, finds that:
1. Methiopropamine Has a High Potential for Abuse Methiopropamine, similar to the schedule II stimulants amphetamine and methamphetamine, is a stimulant with a high potential for abuse. In animals, behavioral locomotor studies
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show that methiopropamine produces stimulation similar to that of methamphetamine. As HHS mentions, methiopropamine abuse in humans has been reported in at least 16 countries, including North America and Europe.
Additionally, typical stimulant effects such as euphoria, psychomotor stimulation, and anxiety have been described from self-reports of methiopropamine abusers. These effects are similar to those of schedule II
stimulant such as methamphetamine and amphetamine. These data collectively indicate that methiopropamine has a high potential for abuse similar to other substances in schedule II such as amphetamine and methamphetamine.
2. Methiopropamine Currently Has No Accepted Medical Use in Treatment in the United States According to HHS, FDA has not approved a marketing application for a drug product containing methiopropamine for any therapeutic indication. As HHS states, there are also no clinical studies or petitioners that claim an accepted medical use in the United States. In addition, as discussed above in the Factor 3 analysis, methiopropamine does not satisfy DEAs five-part test for having a currently accepted medical use in treatment in the United States.
3. There Is a Lack of Accepted Safety for Use of Methiopropamine Under Medical Supervision Currently, methiopropamine does not have an accepted medical use as noted by HHS. Because methiopropamine has no approved medical use in treatment in the United States and has not been investigated as a new drug, its safety for use under medical supervision has not been determined. Thus, there is a lack of accepted safety for use of methiopropamine under medical supervision.
Although the first finding shows methiopropamine to have similar effects to schedule II substances such as amphetamine and methamphetamine, it bears reiterating that there is only one possible schedule in the CSAschedule Ito place methiopropamine since it has no currently accepted medical use in treatment in the United States. See the background section for additional discussion.
Based on these findings, the Administrator concludes that methiopropamine chemical name:
N-methyl-1-thiophen-2-ylpropan-2amine, including its salts, isomers, and salts of isomers, warrants control in schedule I of the CSA. 21 U.S.C.

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812b1. More precisely, because of its stimulant-like effects, DEA is proposing to place methiopropamine in 21 CFR
1308.11f the stimulants category of schedule I. As such, the proposed control of methiopropamine includes the substance as well as its salts, isomers, and salts of isomers.
Requirements for Handling Methiopropamine If this rule is finalized as proposed, methiopropamine would become subject to the CSAs schedule I
regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances, including the following as of the effective date of the planned final scheduling action:
1. Registration. Any person who handles manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses methiopropamine, or who desires to handle methiopropamine, is required to be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312 as of the effective date of a final scheduling action. Any person who currently handles methiopropamine, and is not registered with DEA, would need to submit an application for registration and may not continue to handle methiopropamine as of the effective date of a final scheduling action, unless DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration would be required to surrender all quantities of currently held methiopropamine or to transfer all quantities of currently held methiopropamine to a person registered with DEA before the effective date of a final scheduling action, in accordance with all applicable Federal, State, local, and tribal laws. As of the effective date of a final scheduling action, methiopropamine would be required to be disposed of in accordance with 21
CFR part 1317, in addition to all other applicable Federal, State, local, and tribal laws.
3. Security. Methiopropamine would be subject to schedule I security requirements and would need to be
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