Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Control of the Immediate Precursor Norfentanyl Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance
Document Number: 2020-07381
Type: Rule
Date: 2020-04-17
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is designating the precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) as an immediate precursor for the schedule II controlled substance fentanyl. Furthermore, DEA is finalizing the control of norfentanyl as a schedule II substance under the Controlled Substances Act (CSA).
Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
Document Number: 2020-08001
Type: Notice
Date: 2020-04-16
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Denco, LLC
Document Number: 2020-07999
Type: Notice
Date: 2020-04-16
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 class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration.
Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as List I Chemicals
Document Number: 2020-07064
Type: Rule
Date: 2020-04-15
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is finalizing the designation of N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (also known as benzylfentanyl), including its salts, and N-phenylpiperidin-4- amine (also known as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4- AP) (hereinafter referred to as 4-anilinopiperidine), including its amides, its carbamates, and its salts, as list I chemicals under the Controlled Substances Act (CSA). DEA proposed control of benzylfentanyl and 4-anilinopiperidine due to their use in clandestine laboratories to illicitly manufacture the schedule II controlled substance fentanyl. This rulemaking finalizes the control of benzylfentanyl and 4- anilinopiperidine as list I chemicals.
Adjustments to Aggregate Production Quotas for Certain Schedule II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine and Pseudoephedrine for 2020, in Response to the Coronavirus Disease 2019 Public Health Emergency
Document Number: 2020-07593
Type: Notice
Date: 2020-04-10
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is adjusting the 2020 aggregate production quotas for certain controlled substances in schedule II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine and pseudoephedrine. This increase is in response to the current nationwide COVID-19 public health emergency as declared by the Secretary of Health and Human Services on January 31, 2020.
Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I; Correction
Document Number: 2020-06984
Type: Rule
Date: 2020-04-10
Agency: Drug Enforcement Administration, Department of Justice
In the February 6, 2018, issue of the Federal Register, the Drug Enforcement Administration published a temporary scheduling order placing fentanyl-related substances, as defined in the order, and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I of the Controlled Substances Act. That order was set to expire on February 6, 2020. However, the ``Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act,'' which became law on February 6, 2020, extended the temporary control of fentanyl-related substances until May 6, 2021. This correcting amendment reflects the new expiration date mandated by Congress for the temporary scheduling order.
Bulk Manufacturer of Controlled Substances Application: Benuvia Therapeutics Inc.
Document Number: 2020-07279
Type: Notice
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem
Document Number: 2020-07277
Type: Notice
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI)
Document Number: 2020-07273
Type: Notice
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of 4,4′-DMAR in Schedule I
Document Number: 2020-07095
Type: Proposed Rule
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing the substance 4,4'-DMAR (Chemical name: 4,4'-dimethylaminorex), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the 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 with, or possess), or propose to handle 4,4'-DMAR.
Schedules of Controlled Substances: Placement of Lemborexant in Schedule IV
Document Number: 2020-07089
Type: Rule
Date: 2020-04-07
Agency: Drug Enforcement Administration, Department of Justice
On December 20, 2019, the U.S. Food and Drug Administration approved a new drug application for Dayvigo (lemborexant) tablets for oral use. Lemborexant is chemically known as (1R,2S)-2-[(2,4- dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-N-(5- fluoropyridin-2-yl)cyclopropane-1-carboxamide. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lemborexant in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing 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.
Gregory L. Molden, M.D.; Decision and Order
Document Number: 2020-07018
Type: Notice
Date: 2020-04-03
Agency: Drug Enforcement Administration, Department of Justice
Brewster Drug, Inc.; Decision and Order
Document Number: 2020-07017
Type: Notice
Date: 2020-04-03
Agency: Drug Enforcement Administration, Department of Justice
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