Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Importer of Controlled Substances Application: Andersonbrecon Inc. DBA PCI of Illinois
Document Number: 2021-12819
Type: Notice
Date: 2021-06-17
Agency: Drug Enforcement Administration, Department of Justice
Andersonbrecon Inc. DBA PCI of Illinois 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: Organix Inc.
Document Number: 2021-12817
Type: Notice
Date: 2021-06-17
Agency: Drug Enforcement Administration, Department of Justice
Organix 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.
Importer of Controlled Substances Application: Xcelience
Document Number: 2021-12816
Type: Notice
Date: 2021-06-17
Agency: Drug Enforcement Administration, Department of Justice
Xcelience 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: AMPAC Fine Chemicals Virginia, LLC
Document Number: 2021-12812
Type: Notice
Date: 2021-06-17
Agency: Drug Enforcement Administration, Department of Justice
AMPAC Fine Chemicals Virginia, LLC. 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.
Tareq A. Khedir Al-Tiae, M.D.; Decision and Order
Document Number: 2021-12755
Type: Notice
Date: 2021-06-17
Agency: Drug Enforcement Administration, Department of Justice
Johnny C. Benjamin, Jr., M.D.; Decision and Order
Document Number: 2021-12753
Type: Notice
Date: 2021-06-17
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Usona Institute
Document Number: 2021-12353
Type: Notice
Date: 2021-06-14
Agency: Drug Enforcement Administration, Department of Justice
Usona 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.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2021-12350
Type: Notice
Date: 2021-06-14
Agency: Drug Enforcement Administration, Department of Justice
Fisher 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.
Schedules of Controlled Substances: Placement of N-Ethylpentylone in Schedule I
Document Number: 2021-12261
Type: Rule
Date: 2021-06-14
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration places 1-(1,3-benzodioxol- 5-yl)-2-(ethylamino)pentan-1-one (known as N-ethylpentylone or ephylone) and its optical, positional, and geometric isomers, salts, 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 makes permanent the current imposition of 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, or possess), or propose to handle N-ethylpentylone.
Importer of Controlled Substances Application: Adiramedica, LLC
Document Number: 2021-12290
Type: Notice
Date: 2021-06-11
Agency: Drug Enforcement Administration, Department of Justice
Adiramedica, 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.
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2021-12215
Type: Notice
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
Cambrex Charles City 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: Maridose, LLC
Document Number: 2021-12213
Type: Notice
Date: 2021-06-10
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 its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2021-12212
Type: Notice
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
Fisher 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.
Importer of Controlled Substances Application: National Center for Natural Products Research
Document Number: 2021-12209
Type: Notice
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
National Center for Natural Products Research 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.
Schedules of Controlled Substances: Placement of Oliceridine in Schedule II
Document Number: 2021-11981
Type: Rule
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
This final rule adopts, with a change as mentioned below, an interim final rule with request for comments published in the Federal Register on October 30, 2020, placing oliceridine, N-[(3- methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6- oxaspiro[4.5]decan-9-yl]ethyl{time} )amine fumarate, 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 II of the Controlled Substances Act. In response to an error in the chemical name of oliceridine as noted by one of the commenters to the interim final rule, the Drug Enforcement Administration makes a correction to the above mentioned chemical name of oliceridine by removing the word ``fumarate'' to read as N-[(3- methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6- oxaspiro[4.5]decan-9-yl]ethyl{time} amine. This change clarifies the control of oliceridine free base and its salts, to include the fumarate salt, by definition.
Schedules of Controlled Substances: Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA in Schedule I
Document Number: 2021-11974
Type: Rule
Date: 2021-06-10
Agency: Drug Enforcement Administration, Department of Justice
By this rule, the Drug Enforcement Administration permanently places five synthetic cannabinoids, as identified in this final rule, in schedule I of the Controlled Substances Act. These five substances are currently listed in Schedule I pursuant to a temporary scheduling order. As a result of this rule, 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 these five specified controlled substances will continue to apply.
Jennifer L. St. Croix, M.D.; Order Denying Motion To Stay
Document Number: 2021-11982
Type: Notice
Date: 2021-06-08
Agency: Drug Enforcement Administration, Department of Justice
Designation of 3,4-MDP-2-P Methyl Glycidate (PMK Glycidate), 3,4-MDP-2-P Methyl Glycidic Acid (PMK Glycidic Acid), and Alpha-Phenylacetoacetamide (APAA) as List I Chemicals; Correction
Document Number: 2021-11836
Type: Rule
Date: 2021-06-07
Agency: Drug Enforcement Administration, Department of Justice
On May 10, 2021, the Drug Enforcement Administration published a final rule designating three chemicals, known as PMK glycidate, PMK glycidic acid, and APAA, as list I chemicals under the Controlled Substances Act (CSA). In an amendatory instruction, information specifying the precise location for entries added to a table was inadvertently omitted, which makes enactment of the amendment unworkable. This document corrects that omission.
Schedules of Controlled Substances: Placement of Remimazolam in Schedule IV
Document Number: 2021-11512
Type: Rule
Date: 2021-06-02
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 October 6, 2020, placing the substance remimazolam, 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, DEA maintains remimazolam, 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.
Importer of Controlled Substances Application: Purisys, LLC
Document Number: 2021-11070
Type: Notice
Date: 2021-05-26
Agency: Drug Enforcement Administration, Department of Justice
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.
Importer of Controlled Substances Application: Almac Clinical Services Incorp. (ACSI)
Document Number: 2021-11069
Type: Notice
Date: 2021-05-26
Agency: Drug Enforcement Administration, Department of Justice
Almac Clinical Services Incorp. (ACSI) 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: American Radiolabeled Chem
Document Number: 2021-10996
Type: Notice
Date: 2021-05-25
Agency: Drug Enforcement Administration, Department of Justice
American Radiolabeled Chem 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.
Importer of Controlled Substances Application: SpecGX, LLC
Document Number: 2021-10995
Type: Notice
Date: 2021-05-25
Agency: Drug Enforcement Administration, Department of Justice
SpecGX, 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.
Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V
Document Number: 2021-10827
Type: Rule
Date: 2021-05-24
Agency: Drug Enforcement Administration, Department of Justice
This final rule adopts an interim final rule with request for comments published in the Federal Register on January 31, 2020, placing lasmiditan (2,4,6-trifluoro-N-(6-(1-methylpiperidine-4- carbonyl)pyridine-2-yl-benzamide), including its salts, in schedule V of the Controlled Substances Act without change, apart from a minor amendment to the placement ordering of lasmiditan already made by intervening rules. With the issuance of this final rule, the Drug Enforcement Administration maintains lasmiditan, including its salts, in schedule V of the Controlled Substances Act.
Importer of Controlled Substances Application: Lipomed
Document Number: 2021-10420
Type: Notice
Date: 2021-05-18
Agency: Drug Enforcement Administration, Department of Justice
Lipomed 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: SPECGX LLC
Document Number: 2021-10412
Type: Notice
Date: 2021-05-18
Agency: Drug Enforcement Administration, Department of Justice
SPECGX LLC, 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.
Importer of Controlled Substances Application: Experic LLC
Document Number: 2021-10410
Type: Notice
Date: 2021-05-18
Agency: Drug Enforcement Administration, Department of Justice
Experic 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.
Importer of Controlled Substances Application: Unither Manufacturing LLC
Document Number: 2021-10407
Type: Notice
Date: 2021-05-18
Agency: Drug Enforcement Administration, Department of Justice
Unither Manufacturing 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: Patheon API Manufacturing, Inc.
Document Number: 2021-09988
Type: Notice
Date: 2021-05-12
Agency: Drug Enforcement Administration, Department of Justice
Patheon API Manufacturing, 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.
Rosa A. Fuentes, M.D.; Decision and Order
Document Number: 2021-09907
Type: Notice
Date: 2021-05-11
Agency: Drug Enforcement Administration, Department of Justice
Designation of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and alpha-phenylacetoacetamide (APAA) as List I Chemicals
Document Number: 2021-09697
Type: Rule
Date: 2021-05-10
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is finalizing a December 21, 2020, notice of proposed rulemaking to designate three chemicals, known as PMK glycidate, PMK glycidic acid, and APAA, as list I chemicals under the Controlled Substances Act (CSA). PMK glycidate and PMK glycidic acid are used in and are important to the manufacture of the schedule I controlled substance 3,4-methylenedioxymethamphetamine (MDMA) and other ``ecstasy''-type substances, and APAA is used in and is important to the manufacture of the schedule II controlled substances amphetamine and methamphetamine. This final rulemaking subjects handlers (manufacturers, distributors, importers, and exporters) of PMK glycidate, PMK glycidic acid, and APAA to the chemical regulatory provisions of the CSA and its implementing regulations.
Schedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV
Document Number: 2021-09738
Type: Rule
Date: 2021-05-07
Agency: Drug Enforcement Administration, Department of Justice
On March 2, 2021, the United States Food and Drug Administration approved a new drug application for AZSTARYS capsules for oral use, a combination drug product containing serdexmethylphenidate chloride and dexmethylphenidate hydrochloride, for the treatment of Attention Deficit Hyperactivity Disorder in patients six years of age or older. The Department of Health and Human Services provided the Drug Enforcement Administration with a scheduling recommendation to place serdexmethylphenidate and its salts in schedule IV of the Controlled Substances Act. In accordance with the Controlled Substances Act, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, Drug Enforcement Administration is hereby issuing an interim final rule placing serdexmethylphenidate, including its salts, isomers, and salts of isomers, in schedule IV of the Controlled Substances Act, thereby facilitating the commercial distribution of AZSTARYS as a lawful controlled substance.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Green Rush Organic Farms Inc.
Document Number: 2021-09663
Type: Notice
Date: 2021-05-07
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 its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Indian Flower LLC
Document Number: 2021-09662
Type: Notice
Date: 2021-05-07
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 its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Michele L. Martinho, M.D.; Decision and Order
Document Number: 2021-09464
Type: Notice
Date: 2021-05-05
Agency: Drug Enforcement Administration, Department of Justice
Melanie Baker, N.P.; Decision and Order
Document Number: 2021-09463
Type: Notice
Date: 2021-05-05
Agency: Drug Enforcement Administration, Department of Justice
Emmanuel A. Ayodele, M.D.; Decision and Order
Document Number: 2021-09461
Type: Notice
Date: 2021-05-05
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Four Specific Fentanyl-Related Substances in Schedule I
Document Number: 2021-09402
Type: Rule
Date: 2021-05-04
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration places four specified fentanyl-related substances permanently 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. 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, or possess), or propose to handle any of these four specified fentanyl-related substances will continue to be applicable permanently as a result of this action.
Importer of Controlled Substances Application: VHG Labs DBA LGC Standards
Document Number: 2021-09302
Type: Notice
Date: 2021-05-04
Agency: Drug Enforcement Administration, Department of Justice
VHG Labs DBA LGC Standards 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: Cargill, Incorporated
Document Number: 2021-09301
Type: Notice
Date: 2021-05-04
Agency: Drug Enforcement Administration, Department of Justice
Cargill, 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.
Importer of Controlled Substances Application: Wildlife Laboratories, LLC
Document Number: 2021-09300
Type: Notice
Date: 2021-05-04
Agency: Drug Enforcement Administration, Department of Justice
Wildlife 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.
Schedules of Controlled Substances: Placement of 10 Specific Fentanyl-Related Substances in Schedule I
Document Number: 2021-08720
Type: Rule
Date: 2021-04-27
Agency: Drug Enforcement Administration, Department of Justice
In this rule, the Drug Enforcement Administration places 10 specified fentanyl-related substances permanently in schedule I of the Controlled Substances Act. These 10 specific substances all fall within the definition of fentanyl-related substances set forth in a 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. 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, or possess), or propose to handle any of these 10 specified fentanyl-related substances will continue to be applicable permanently as a result of this action.
Agency Information Collection Activities; Proposed eCollection, eComments Requested; New Proposed Collection Exempt Chemical Preparations Application
Document Number: 2021-08586
Type: Notice
Date: 2021-04-26
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA), Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Importer of Controlled Substances Application: Rhodes Technologies
Document Number: 2021-08539
Type: Notice
Date: 2021-04-26
Agency: Drug Enforcement Administration, Department of Justice
Rhodes Technologies 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: Rhodes Technologies
Document Number: 2021-08544
Type: Notice
Date: 2021-04-23
Agency: Drug Enforcement Administration, Department of Justice
Rhodes Technologies 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.
Importer of Controlled Substances Application: Cardinal Health
Document Number: 2021-08537
Type: Notice
Date: 2021-04-23
Agency: Drug Enforcement Administration, Department of Justice
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.
Importer of Controlled Substances Application: Lipomed
Document Number: 2021-08535
Type: Notice
Date: 2021-04-23
Agency: Drug Enforcement Administration, Department of Justice
Lipomed 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.
Exempt Chemical Preparations Under the Controlled Substances Act
Document Number: 2021-06689
Type: Notice
Date: 2021-04-23
Agency: Drug Enforcement Administration, Department of Justice
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.
Javaid A. Perwaiz, M.D.; Decision and Order
Document Number: 2021-08173
Type: Notice
Date: 2021-04-21
Agency: Drug Enforcement Administration, Department of Justice
Mark A. Wimbley, M.D.; Decision and Order
Document Number: 2021-08171
Type: Notice
Date: 2021-04-21
Agency: Drug Enforcement Administration, Department of Justice