Drug Enforcement Administration March 3, 2021 – Federal Register Recent Federal Regulation Documents
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Schedules of Controlled Substances: Placement of 10 Specific Fentanyl-Related Substances in Schedule I
The Drug Enforcement Administration proposes placing N-(1-(2- fluorophenethyl)piperidin-4-yl)-N-(2-fluorophenyl)propionamid e (2'- fluoro ortho-fluorofentanyl), N-(1-(4-methylphenethyl)piperidin-4-yl)- N-phenylacetamide (4'-methyl acetyl fentanyl), N-(1-phenethylpiperidin- 4-yl)-N,3-diphenylpropanamide ([beta]'-phenyl fentanyl; 3- phenylpropanoyl fentanyl), N-phenyl-N-(1-(2-phenylpropyl)piperidin-4- yl)propionamide ([beta]-methyl fentanyl), N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)butyramide (ortho-fluorobutyryl fentanyl; 2- fluorobutyryl fentanyl), N-(2-methylphenyl)-N-(1-phenethylpiperidin-4- yl)acetamide (ortho-methyl acetylfentanyl; 2-methyl acetylfentanyl), 2- methoxy-N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)aceta mide (ortho-methyl methoxyacetylfentanyl), N-(4-methylphenyl)-N-(1- phenethylpiperidin-4-yl)propionamide (para-methylfentanyl; 4- methylfentanyl), N-(1-phenethylpiperidin-4-yl)-N-phenylbenzamide (phenyl fentanyl; benzoyl fentanyl), N-(1-phenethylpiperidin-4-yl)-N- phenylthiophene-2-carboxamide (thiofuranyl fentanyl), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, in schedule I of the Controlled Substances Act. These ten specific substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018, temporary scheduling order. Through the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 2'- fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho- methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para- methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl.
Schedules of Controlled Substances: Placement of Lemborexant in Schedule IV
This final rule adopts, without change, an interim final rule with request for comments published in the Federal Register on April 7, 2020, placing lemborexant ((1R,2S)-2-[(2,4-dimethylpyrimidin-5- yl)oxymethyl]-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cycl opropane- 1-carboxamide), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the Controlled Substances Act (CSA). With the issuance of this final rule, the Drug Enforcement Administration maintains lemborexant, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.
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