Drug Enforcement Administration March 2021 – Federal Register Recent Federal Regulation Documents
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Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl in Schedule I; Correction
The Drug Enforcement Administration is correcting a final rule that appeared in the Federal Register on November 25, 2020. The document issued an action placing five fentanyl-related substances (cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N- (1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, permanently in schedule I of the Controlled Substances Act, specifically to the opiates list under DEA regulations. The published document assigned incorrect paragraph numbers to all five substances, and inadvertently removed four other substances from the listed opiates.
Schedules of Controlled Substances: Extension of Temporary Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 in Schedule I of the Controlled Substances Act
The Acting Administrator of the Drug Enforcement Administration is issuing this order to extend the temporary schedule I status of ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate (trivial name: 5F-EDMB-PINACA); methyl 2-(1-(5- fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole- 3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4- fluorobenzyl)); 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole- 3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4- fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)m ethanone (trivial name: FUB-144), and their optical, positional, and geometric isomers, salts, and salts of isomers. The schedule I status of 5F-EDMB- PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 currently is in effect until April 16, 2021. This temporary order will extend the temporary scheduling of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F- CUMYL-PINACA and FUB-144 for one year or until the permanent scheduling action for these substances is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 in Schedule I
The Drug Enforcement Administration proposes placing ethyl 2- (1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbu tanoate (trivial name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1H-indole- 3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N- (adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-fluorobenzyl)); 1-(5- fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxami de (trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1H- indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name: FUB-144), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. 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, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 5F-EDMB- PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144.
Designation of Methyl alpha-phenylacetoacetate, a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical
The Drug Enforcement Administration is proposing the control of the chemical methyl alpha-phenylacetoacetate (also known as MAPA; methyl 3-oxo-2-phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]- acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5) and its optical isomers as a list I chemical under the Controlled Substances Act (CSA). Methyl alpha-phenylacetoacetate is used in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine and is important to the manufacture of these controlled substances. If finalized, this action would subject handlers of methyl alpha-phenylacetoacetate to the chemical regulatory provisions of the CSA and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of methyl alpha- phenylacetoacetate. As such, all transactions of chemical mixtures containing methyl alpha-phenylacetoacetate would be regulated at any concentration and would be subject to control under the CSA.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: MMJ 95, LLC
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Importer of Controlled Substances Application: Shertech Laboratories, LLC
Shertech Laboratories, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Medi-Physics Inc dba GE Healthcare
Medi-Physics Inc dba GE Healthcare has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Perkinelmer, Inc.
Perkinelmer, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Schedules of Controlled Substances: Placement of Four Specific Fentanyl-Related Substances in Schedule I
The Drug Enforcement Administration proposes placing ethyl (1- phenethylpiperidin-4-yl)(phenyl)carbamate (fentanyl carbamate), N-(2- fluorophenyl)-N-(1-phenethylpiperidin-4-yl)acrylamide (ortho- fluoroacryl fentanyl), N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide (ortho-fluoroisobutyryl fentanyl), and N-(4- fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamid e (para- fluoro furanyl fentanyl), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, in schedule I of the Controlled Substances Act. These four 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 fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl.
Bulk Manufacturer of Controlled Substances Application: Noramco Coventry, LLC.
Noramco Coventry, LLC. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Lab; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register of September 14, 2020, concerning a notice of application. The document contained a misspelling (Isotype vs. Isotope).
Importer of Controlled Substances Application: Purisys, LLC
Purisys, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Groff NA Hemplex LLC
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc
Patheon Pharmaceuticals Inc has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Stepan Company
Stepan Company has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
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.
Importer of Controlled Substances Application: Stepan Company
Stepan Company has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Schedules of Controlled Substances: Temporary Placement of Brorphine in Schedule I
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary order to schedule 1-(1-(1-(4- bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-benzo[d]imid azol-2-one (commonly known as brorphine), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act . This action is based on a finding by the Acting Administrator that the placement of brorphine in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle brorphine.
Importer of Controlled Substances Application: Groff NA Hemplex, LLC
Groff NA Hemplex, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Cosmic Light LLC
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Importer of Controlled Substances Application: Microgenics Corporation Thermo Fisher Scientific
Microgenics Corporation Thermo Fisher Scientific has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
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