Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Importer of Controlled Substances Application: Purisys, LLC
Document Number: 2021-16142
Type: Notice
Date: 2021-07-29
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.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Nusachi Labs, LLC.
Document Number: 2021-16141
Type: Notice
Date: 2021-07-29
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: AMPAC Fine Chemicals, LLC
Document Number: 2021-16137
Type: Notice
Date: 2021-07-29
Agency: Drug Enforcement Administration, Department of Justice
AMPAC Fine Chemicals, 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.
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2021-16136
Type: Notice
Date: 2021-07-29
Agency: Drug Enforcement Administration, Department of Justice
Cerilliant Corporation 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.
Care Point Pharmacy, Inc.; Decision and Order
Document Number: 2021-16005
Type: Notice
Date: 2021-07-28
Agency: Drug Enforcement Administration, Department of Justice
William Ralph Kinkaid, M.D.; Decision and Order
Document Number: 2021-16004
Type: Notice
Date: 2021-07-28
Agency: Drug Enforcement Administration, Department of Justice
Erica N. Grant, M.D.; Decision and Order
Document Number: 2021-16003
Type: Notice
Date: 2021-07-28
Agency: Drug Enforcement Administration, Department of Justice
Creekbend Community Pharmacy; Decision and Order
Document Number: 2021-16000
Type: Notice
Date: 2021-07-28
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Novitium Pharma, LLC
Document Number: 2021-15920
Type: Notice
Date: 2021-07-27
Agency: Drug Enforcement Administration, Department of Justice
Novitium Pharma, 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: Catalent Pharma Solutions, LLC.
Document Number: 2021-15919
Type: Notice
Date: 2021-07-27
Agency: Drug Enforcement Administration, Department of Justice
Catalent Pharma Solutions, 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: Arizona Department of Corrections
Document Number: 2021-15710
Type: Notice
Date: 2021-07-23
Agency: Drug Enforcement Administration, Department of Justice
Arizona Department of Corrections 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 Amineptine in Schedule I
Document Number: 2021-15331
Type: Proposed Rule
Date: 2021-07-22
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing the substance amineptine (chemical name: 7-[(10,11-dihydro-5H- dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid), 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 United Nations 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, amineptine.
Exempt Chemical Preparations Under the Controlled Substances Act
Document Number: 2021-15024
Type: Notice
Date: 2021-07-22
Agency: Drug Enforcement Administration, Department of Justice
The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between September 1, 2020, and March 31, 2021, as listed below, were accepted for filing and have been approved or denied as indicated.
Clarification Regarding the Supplier's DEA Registration Number on the Single-Sheet DEA Form 222
Document Number: 2021-15323
Type: Rule
Date: 2021-07-20
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is issuing this direct final rule to amend DEA regulations to clarify that either the purchaser or the supplier may enter a supplier's DEA registration number on the Single-Sheet DEA Form 222.
Schedules of Controlled Substances: Placement of N-Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-Methyl-alpha-ethylaminopentiophenone, 4′-Methyl-alpha-pyrrolidinohexiophenone, alpha-Pyrrolidinoheptaphenone, and 4′-Chloro-alpha-pyrrolidinovalerophenone in Schedule I
Document Number: 2021-15114
Type: Proposed Rule
Date: 2021-07-16
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing six synthetic cathinones, as identified in this proposed rule, 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these six specified controlled substances.
Schedules of Controlled Substances: Extension of Temporary Placement of N
Document Number: 2021-15113
Type: Rule
Date: 2021-07-16
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this order to extend the temporary schedule I status of six synthetic cathinones, as identified in this order. The schedule I status of these six substances currently is in effect until July 18, 2021. This temporary order extends the temporary scheduling of these six substances for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first.
Importer of Controlled Substances Application: Alcami Carolinas Corporation
Document Number: 2021-14533
Type: Notice
Date: 2021-07-08
Agency: Drug Enforcement Administration, Department of Justice
Alcami Carolinas Corporation 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: Aspen API, Inc.
Document Number: 2021-14530
Type: Notice
Date: 2021-07-08
Agency: Drug Enforcement Administration, Department of Justice
Aspen API, 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: United States Pharmacopeial Convention
Document Number: 2021-14210
Type: Notice
Date: 2021-07-02
Agency: Drug Enforcement Administration, Department of Justice
United States Pharmacopeial Convention 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.
Spring Valley Family Pharmacy; Decision and Order
Document Number: 2021-14165
Type: Notice
Date: 2021-07-02
Agency: Drug Enforcement Administration, Department of Justice
Keith A. Jenkins, N.P.; Decision and Order
Document Number: 2021-14163
Type: Notice
Date: 2021-07-02
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2021-13672
Type: Notice
Date: 2021-06-28
Agency: Drug Enforcement Administration, Department of Justice
AMRI Rensselaer, 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.
Bulk Manufacturer of Controlled Substances Application: Chemic Laboratories
Document Number: 2021-13671
Type: Notice
Date: 2021-06-28
Agency: Drug Enforcement Administration, Department of Justice
Chemic Laboratories, 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.
Registration Requirements for Narcotic Treatment Programs With Mobile Components
Document Number: 2021-13519
Type: Rule
Date: 2021-06-28
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is publishing this final rule to revise existing regulations for narcotic treatment programs (NTPs) to allow the operation of a mobile component associated with a DEA-registered NTP to be considered a coincident activity permitted under the NTP's registration. Based on these revisions, NTP registrants that operate or wish to operate mobile components (in the State in which the registrant is registered) to dispense narcotic drugs in schedules II-V at remote location(s) for the purpose of maintenance or detoxification treatment do not need a separate registration for such mobile component. This final rule waives 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 this rule. 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.
Carol Hippenmeyer, M.D.; Decision and Order
Document Number: 2021-13526
Type: Notice
Date: 2021-06-25
Agency: Drug Enforcement Administration, Department of Justice
Robert Wayne Locklear, M.D.; Decision and Order
Document Number: 2021-13525
Type: Notice
Date: 2021-06-25
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of para-Methoxymethamphetamine (PMMA) in Schedule I
Document Number: 2021-13460
Type: Rule
Date: 2021-06-25
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places 1-(4-methoxyphenyl)-N-methylpropan-2-amine (para- methoxymethamphetamine, PMMA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, in schedule I of the Controlled Substances Act to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes 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 PMMA.
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Document Number: 2021-13252
Type: Notice
Date: 2021-06-24
Agency: Drug Enforcement Administration, Department of Justice
Cambrex Charles City 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.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Annac Medical Center LC
Document Number: 2021-13249
Type: Notice
Date: 2021-06-24
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 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: Purisys, LLC.
Document Number: 2021-13096
Type: Notice
Date: 2021-06-23
Agency: Drug Enforcement Administration, Department of Justice
Purisys, 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.
Specific Listing for 4F-MDMB-BINACA, a Currently Controlled Schedule I Substance
Document Number: 2021-13040
Type: Rule
Date: 2021-06-22
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is establishing a specific listing and Administration Controlled Substances Code Number (drug code) for 4F-MDMB-BINACA (also known as 4F-MDMB-BUTINACA or methyl 2- (1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbut anoate) in schedule I of the Controlled Substances Act (CSA). Although 4F-MDMB- BINACA is not specifically listed in schedule I of the CSA with its own unique drug code, it has been controlled in the United States since April 2017 as a positional isomer of 5F-AMB, a schedule I hallucinogen. Therefore, DEA is simply amending the schedule I hallucinogenic substances list in its regulations to separately include 4F-MDMB- BINACA.
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.