Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Importer of Controlled Substances Application: Shertech Laboratories, LLC
Document Number: 2020-06762
Type: Notice
Date: 2020-04-01
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Wildlife Laboratories, Inc.
Document Number: 2020-06759
Type: Notice
Date: 2020-04-01
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of FUB-AMB in Schedule I
Document Number: 2020-06176
Type: Rule
Date: 2020-03-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) places methyl 2-(1- (4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its 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. This action continues the imposition of the 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, or possess), or propose to handle FUB-AMB.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2020-06175
Type: Notice
Date: 2020-03-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories, Inc.
Document Number: 2020-06168
Type: Notice
Date: 2020-03-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sharp (Bethlehem), LLC
Document Number: 2020-06167
Type: Notice
Date: 2020-03-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cargill, Inc.
Document Number: 2020-06165
Type: Notice
Date: 2020-03-24
Agency: Drug Enforcement Administration, Department of Justice
Controls To Enhance the Cultivation of Marihuana for Research in the United States
Document Number: 2020-05796
Type: Proposed Rule
Date: 2020-03-23
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is proposing to amend its regulations to comply with the requirements of the Controlled Substances Act, including consistency with treaty obligations, in order to facilitate the cultivation of marihuana for research purposes and other licit purposes. Specifically, this proposed rule would amend the provisions of the regulations governing applications by persons seeking to become registered with DEA to grow marihuana as bulk manufacturers and add provisions related to the purchase and sale of this marihuana by DEA.
John O. Dimowo, M.D.; Decision and Order
Document Number: 2020-05751
Type: Notice
Date: 2020-03-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Navinta LLC
Document Number: 2020-05750
Type: Notice
Date: 2020-03-19
Agency: Drug Enforcement Administration, Department of Justice
Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants
Document Number: 2020-05159
Type: Proposed Rule
Date: 2020-03-16
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes adjusting the fee schedule for registration and reregistration fees necessary to recover the costs of its Diversion Control Program relating to the registration and control of the manufacture, distribution, dispensing, importation and exportation of controlled substances and list I chemicals as mandated by the Controlled Substances Act.
Schedules of Controlled Substances: Placement of Cenobamate in Schedule V
Document Number: 2020-04963
Type: Rule
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
On November 21, 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application for XCOPRI (cenobamate) tablets. Cenobamate is chemically known as [(1R)-1-(2-chlorophenyl)-2-(tetrazol- 2-yl)ethyl] carbamate. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place cenobamate in schedule V of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing cenobamate, including its salts, in schedule V of the CSA.
William S. Husel, D.O.; Decision and Order
Document Number: 2020-04837
Type: Notice
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2020-04836
Type: Notice
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Caligor Pharma Services
Document Number: 2020-04835
Type: Notice
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: SpecGx LLC
Document Number: 2020-04834
Type: Notice
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Arizona Department of Corrections
Document Number: 2020-04833
Type: Notice
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics Inc.
Document Number: 2020-04832
Type: Notice
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research
Document Number: 2020-04831
Type: Notice
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: S&B Pharma, Inc.; Correction
Document Number: 2020-04829
Type: Notice
Date: 2020-03-10
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published a document in the Federal Register on November 22, 2019, concerning a notice of application. As that document correctly indicated, the applicant, S&B Pharma, Inc., DBA Norac Pharma, 405 South Motor Avenue, Azusa, California 91702-3232 applied to be registered as a bulk manufacturer of a number of controlled substances, to include applying for authorization in order to synthetically manufacture using drug code 7360 (marihuana). However, on the notice of application published, drug code 7360 was inadvertently identified and listed as Gamma Hydroxybutyric Acid instead of Marihuana.
Registration Requirements for Narcotic Treatment Programs With Mobile Components
Document Number: 2020-03627
Type: Proposed Rule
Date: 2020-02-26
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to revise the existing regulations for narcotic treatment programs (NTPs) to allow a mobile component associated with the registered program to be considered a coincident activity. The NTP registrants that operate or wish to operate mobile components (in the state that the registrant is registered in) to dispense narcotic drugs in schedules II-V at a remote location for the purpose of maintenance or detoxification treatment would not be required to obtain a separate registration for a mobile component. This proposed rule would waive the requirement of a separate registration at each principal place of business or professional practice where controlled substances are dispensed for those NTPs with mobile components that fully comply with the requirements of the proposed rule, once finalized. These revisions to the regulations are intended to make maintenance or detoxification treatments more widely available, while ensuring that safeguards are in place to reduce the likelihood of diversion.
Jaime C. David, M.D.; Decision and Order
Document Number: 2020-03626
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Irvine Labs, Inc.
Document Number: 2020-03623
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration.
Importer of Controlled Substances Application: PerkinElmer, Inc.
Document Number: 2020-03620
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Research Triangle Institute
Document Number: 2020-03619
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Stepan Company
Document Number: 2020-03618
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc.
Document Number: 2020-03617
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Synthcon, LLC
Document Number: 2020-03616
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Document Number: 2020-03612
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute
Document Number: 2020-03611
Type: Notice
Date: 2020-02-24
Agency: Drug Enforcement Administration, Department of Justice
Solomon Adu-Beniako, M.D.; Decision and Order
Document Number: 2020-01971
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Theresa L. Wendt, N.P.; Decision and Order
Document Number: 2020-01970
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Kambiz Haghighi, M.D.; Decision and Order
Document Number: 2020-01969
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Andrzej Kazimierz Zielke, M.D.; Decision and Order
Document Number: 2020-01968
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Shelton W. Barnes, M.D.; Decision and Order
Document Number: 2020-01967
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Spocannabis LLC
Document Number: 2020-01966
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC
Document Number: 2020-01960
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco Inc.
Document Number: 2020-01959
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Stepan Company
Document Number: 2020-01958
Type: Notice
Date: 2020-02-03
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V
Document Number: 2020-01957
Type: Rule
Date: 2020-01-31
Agency: Drug Enforcement Administration, Department of Justice
On October 11, 2019, the U.S. Food and Drug Administration approved a new drug application for Reyvow (lasmiditan) tablets for oral use. Lasmiditan is chemically known as [2,4,6-trifluoro-N-(6-(1- methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide]. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lasmiditan in schedule V of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing lasmiditan, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule V of the CSA.
Schedules of Controlled Substances: Extension of Temporary Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl in Schedule I of the Controlled Substances Act
Document Number: 2020-01683
Type: Rule
Date: 2020-01-30
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of 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. The schedule I status of cyclopentyl fentanyl, isobutyryl fentanyl, para- chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl currently is in effect until February 1, 2020. This temporary order will extend the temporary scheduling of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para- methoxybutyryl fentanyl, and valeryl fentanyl for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl Into Schedule I
Document Number: 2020-01681
Type: Proposed Rule
Date: 2020-01-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing 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 whenever the existence of such isomers, esters, ethers and salts 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, or possess), or propose to handle cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para- methoxybutyryl fentanyl, and valeryl fentanyl.
Additions to Listing of Exempt Chemical Mixtures
Document Number: 2020-00667
Type: Rule
Date: 2020-01-27
Agency: Drug Enforcement Administration, Department of Justice
Under this direct final rule, the Drug Enforcement Administration (DEA) is updating the Table of Exempt Chemical Mixtures to include the listing of 15 additional preparations. This action is in response to DEA's review of new applications for exemption. Having reviewed applications and relevant information, DEA finds that these preparations meet the applicable exemption criteria. Therefore, these products are exempted from the application of certain provisions of the Controlled Substances Act.
Schedules of Controlled Substances: Placement of Brexanolone in Schedule IV
Document Number: 2020-00669
Type: Rule
Date: 2020-01-24
Agency: Drug Enforcement Administration, Department of Justice
This final rule adopts without change an interim final rule with request for comments published in the Federal Register on June 17, 2019. That interim final rule placed the substance brexanolone (3[alpha]-hydroxy-5[alpha]-pregnan-20-one), 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. With the issuance of this final rule, the Drug Enforcement Administration maintains brexanolone in schedule IV of the Controlled Substances Act.
Schedules of Controlled Substances: Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in Schedule I
Document Number: 2020-00665
Type: Rule
Date: 2020-01-24
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration places methyl 2-(1-(5- fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoat e [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5- fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-ind azole-3- carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3- carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA], 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. This action continues the imposition of the 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, or possess), or propose to handle 5F- ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA.
Schedules of Controlled Substances: Removal of 6β-Naltrexol From Control
Document Number: 2020-00664
Type: Rule
Date: 2020-01-24
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Acting Administrator of the Drug Enforcement Administration removes (5[alpha],6[beta])-17- (cyclopropylmethyl)-4,5-epoxymorphinan-3,6,14-triol (6[beta]-naltrexol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA 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, 6[beta]-naltrexol 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 6[beta]-naltrexol.
Importer of Controlled Substances Application: S&B Pharma, Inc.
Document Number: 2020-00661
Type: Notice
Date: 2020-01-17
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV
Document Number: 2019-27955
Type: Rule
Date: 2020-01-07
Agency: Drug Enforcement Administration, Department of Justice
This final rule adopts, without change, an interim final rule with request for comments published in the Federal Register on June 17, 2019, placing solriamfetol (2-amino-3-phenylpropyl carbamate), 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. With the issuance of this final rule, the Drug Enforcement Administration maintains solriamfetol, 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: Myoderm
Document Number: 2019-27954
Type: Notice
Date: 2019-12-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2019-27953
Type: Notice
Date: 2019-12-27
Agency: Drug Enforcement Administration, Department of Justice