Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

Cardinal Health 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.

The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between July 1, 2018, and December 31, 2020, as listed below, were accepted for filing and have been approved or denied as indicated.

Research Triangle Institute 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.

Scottsdale Research Institute 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.

With the issuance of this final rule, the Acting Administrator of the Drug Enforcement Administration removes samidorphan (3- carboxamido-4-hydroxy naltrexone) and its salts from the schedules of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, samidorphan was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle samidorphan.

Royal Emerald Pharmaceuticals Research and Development DBA: Royal Emerald Pharmaceuticals 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.

Sharp Clinical Services, 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

S&B Pharma, 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.

On November 2, 2020, the Drug Enforcement Administration published in the Federal Register a notice of proposed rulemaking (NPRM) soliciting comments on the proposed revisions relating to the suspicious orders of controlled substances. The NPRM provided for a comment period ending on January 4, 2021, and the opportunity to comment ended accordingly. DEA has determined that a reopening of the comment period from February 25, 2021 until March 29, 2021 is appropriate as registrants who would be primarily affected by this rule are uniquely preoccupied with mitigating the global pandemic caused by COVID-19. Accordingly, this reopening will permit additional time to prepare and submit comments.

Sigma Aldrich Research Biochemicals, Inc, 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.