Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

Results 251 - 300 of 4,281
Dylan E. O'Connor, M.D.; Decision and Order
Document Number: 2023-02120
Type: Notice
Date: 2023-02-02
Agency: Drug Enforcement Administration, Department of Justice
Controlled Substances Ordering System (CSOS) Modernization
Document Number: 2023-01804
Type: Proposed Rule
Date: 2023-02-02
Agency: Drug Enforcement Administration, Department of Justice
This rule proposes to amend the Drug Enforcement Administration's (DEA) regulations to conform to the Controlled Substances Ordering System (CSOS) modernization effort by requiring all CSOS enrollment applications and supporting materials to be submitted through the Diversion Control Division secure online portal. These amendments would improve the enrollment process by aligning it with DEA's current requirements for other online form submissions. The online submission of enrollment applications and supporting material through the secure network application portal would increase the efficiency of the enrollment, modification, and revocation processes, and ensure DEA's receipt of accurate documentation in a more timely and organized manner.
Reynaldo De Los Angeles, M.D.; Decision and Order
Document Number: 2023-02132
Type: Notice
Date: 2023-02-02
Agency: Drug Enforcement Administration, Department of Justice
Ester Mark, M.D.; Decision and Order
Document Number: 2023-02128
Type: Notice
Date: 2023-02-02
Agency: Drug Enforcement Administration, Department of Justice
Fernando Mendez, P.A.; Decision and Order
Document Number: 2023-02122
Type: Notice
Date: 2023-02-02
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Globyz Pharma, LLC
Document Number: 2023-01816
Type: Notice
Date: 2023-01-30
Agency: Drug Enforcement Administration, Department of Justice
Globyz Pharma, 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: Organic Consultants LLC DBA Cascade Chemistry
Document Number: 2023-01133
Type: Notice
Date: 2023-01-23
Agency: Drug Enforcement Administration, Department of Justice
Organic Consultants LLC DBA Cascade Chemistry 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: Mylan Pharmaceuticals, Inc.
Document Number: 2023-01208
Type: Notice
Date: 2023-01-23
Agency: Drug Enforcement Administration, Department of Justice
Mylan Pharmaceuticals, Inc. 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: Sunny Enterprises Inc.
Document Number: 2023-01207
Type: Notice
Date: 2023-01-23
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: Medi-Physics Inc. dba GE Healthcare
Document Number: 2023-01206
Type: Notice
Date: 2023-01-23
Agency: Drug Enforcement Administration, Department of Justice
Medi-Physics Inc. dba GE Healthcare 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: Janssen Pharmaceuticals Inc.
Document Number: 2023-01205
Type: Notice
Date: 2023-01-23
Agency: Drug Enforcement Administration, Department of Justice
Janssen Pharmaceuticals 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.
Bulk Manufacturer of Controlled Substances Application: Maridose LLC
Document Number: 2023-01203
Type: Notice
Date: 2023-01-23
Agency: Drug Enforcement Administration, Department of Justice
Maridose 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: Janssen Pharmaceuticals Inc.
Document Number: 2023-01202
Type: Notice
Date: 2023-01-23
Agency: Drug Enforcement Administration, Department of Justice
Janssen Pharmaceuticals Inc. 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: Siegfried USA, LLC
Document Number: 2023-01199
Type: Notice
Date: 2023-01-23
Agency: Drug Enforcement Administration, Department of Justice
Siegfried USA, 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.
Bulk Manufacturer of Controlled Substances Application: Navinta LLC
Document Number: 2023-01047
Type: Notice
Date: 2023-01-20
Agency: Drug Enforcement Administration, Department of Justice
Navinta 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.
Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC
Document Number: 2023-01036
Type: Notice
Date: 2023-01-20
Agency: Drug Enforcement Administration, Department of Justice
Kinetochem 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: VA Cooperative Studies Program
Document Number: 2023-01035
Type: Notice
Date: 2023-01-20
Agency: Drug Enforcement Administration, Department of Justice
VA Cooperative Studies Program 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: Siegfried USA, LLC
Document Number: 2023-01034
Type: Notice
Date: 2023-01-20
Agency: Drug Enforcement Administration, Department of Justice
Siegfried USA, 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: Noramco
Document Number: 2023-01033
Type: Notice
Date: 2023-01-20
Agency: Drug Enforcement Administration, Department of Justice
Noramco 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: Soo Labs II, Inc.
Document Number: 2023-01030
Type: Notice
Date: 2023-01-20
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: Isosciences, LLC
Document Number: 2022-28205
Type: Notice
Date: 2022-12-28
Agency: Drug Enforcement Administration, Department of Justice
Isosciences, 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.
Schedules of Controlled Substances: Removal of Fenfluramine From Control
Document Number: 2022-27400
Type: Rule
Date: 2022-12-23
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration removes fenfluramine (chemical name: N-ethyl-[alpha]- methyl-3-(trifluoromethyl)phenethylamine), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts is possible, from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, fenfluramine was a schedule IV controlled substance. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule IV controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, engage in research, import, export, conduct instructional activities or chemical analysis with, or possess) or propose to handle fenfluramine.
Schedules of Controlled Substances: Temporary Placement of Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam in Schedule I
Document Number: 2022-27278
Type: Proposed Rule
Date: 2022-12-23
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is providing this notice of intent to publish a temporary order to schedule five synthetic benzodiazepine substances, as identified in this notice, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will 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 these five specified controlled substances.
Jennings Staley, M.D.; Decision and Order
Document Number: 2022-27480
Type: Notice
Date: 2022-12-20
Agency: Drug Enforcement Administration, Department of Justice
Allan Alexander Rashford, M.D.; Decision and Order
Document Number: 2022-27479
Type: Notice
Date: 2022-12-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Stepan Company; Correction
Document Number: 2022-26928
Type: Notice
Date: 2022-12-15
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published a document in the Federal Register on August 9, 2022, concerning an application for an Importer of Controlled Substances. The document contained an incorrect drug schedule for coca leaves.
Importer of Controlled Substances Application: VHG Labs dba LGC Standards
Document Number: 2022-26925
Type: Notice
Date: 2022-12-12
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 SUPPLEMENTARY INFORMATION listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute
Document Number: 2022-26922
Type: Notice
Date: 2022-12-12
Agency: Drug Enforcement Administration, Department of Justice
Scottsdale Research Institute 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: Lyndra Therapeutics
Document Number: 2022-26920
Type: Notice
Date: 2022-12-12
Agency: Drug Enforcement Administration, Department of Justice
Lyndra Therapeutics 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: Sterling Pharma USA, LLC
Document Number: 2022-26913
Type: Notice
Date: 2022-12-12
Agency: Drug Enforcement Administration, Department of Justice
Sterling Pharma USA, 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.
Schedules of Controlled Substances: Placement of Methiopropamine in Schedule I
Document Number: 2022-26805
Type: Rule
Date: 2022-12-09
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places N-methyl-1-(thiophen-2-yl)propan-2-amine (methiopropamine), 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. This action imposes 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 methiopropamine.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Alm Management
Document Number: 2022-26208
Type: Notice
Date: 2022-12-02
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: Attitude Wellness
Document Number: 2022-26207
Type: Notice
Date: 2022-12-02
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.
Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2023
Document Number: 2022-26351
Type: Notice
Date: 2022-12-02
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2023 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Kerry Farms LLC
Document Number: 2022-26178
Type: Notice
Date: 2022-12-01
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.
Default Provisions for Hearing Proceedings Relating to the Revocation, Suspension, or Denial of a Registration; Correction
Document Number: 2022-25823
Type: Rule
Date: 2022-11-29
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Agency is correcting a rule that published November 14, 2022, in the Federal Register, to clarify the effective date is 30 days from the date the rule published.
Schedules of Controlled Substances: Placement of Mesocarb in Schedule I
Document Number: 2022-25219
Type: Rule
Date: 2022-11-22
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places mesocarb (chemical name: N-phenyl-N' -(3-(1- phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium-5-yl)carbamimidate), 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. 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 with, or possess), or propose to handle mesocarb.
Schedules of Controlled Substances: Removal of [18
Document Number: 2022-25212
Type: Rule
Date: 2022-11-21
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration removes [\18\F]FP-CIT (chemical names: [\18\F]N-[omega]- fluoropropyl-[beta]-CIT; fluorine-18-N-3-fluoropropyl-2-beta- carbomethoxy-3-beta-(4-iodophenyl)tropane; [\18\F]fluoropropylcarbomethoxy nortropane) from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, [\18\F]FP-CIT was a schedule II controlled substance because it can be derived from cocaine, a schedule II substance, via ecgonine, also a schedule II substance. 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, engage in research, import, export, conduct instructional activities or chemical analysis with, or possess) or propose to handle [\18\F]FP-CIT.
Schedules of Controlled Substances: Placement of Zipeprol in Schedule I
Document Number: 2022-25206
Type: Rule
Date: 2022-11-21
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places zipeprol (chemical name: 1-methoxy-3-[4-(2- methoxy-2-phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol), 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 within the specific chemical designation, 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. 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 with, or possess), or propose to handle zipeprol.
Adley Dasilva, P.A.; Decision and Order
Document Number: 2022-25103
Type: Notice
Date: 2022-11-18
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Berkshire Roots, Inc.
Document Number: 2022-25175
Type: Notice
Date: 2022-11-18
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: Vici Health Sciences, LLC
Document Number: 2022-25174
Type: Notice
Date: 2022-11-18
Agency: Drug Enforcement Administration, Department of Justice
Vici Health Sciences, 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.
Schedules of Controlled Substances: Placement of Amineptine in Schedule I
Document Number: 2022-25003
Type: Rule
Date: 2022-11-17
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final rule, the Drug Enforcement Administration places 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 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 amineptine.
Default Provisions for Hearing Proceedings Relating to the Revocation, Suspension, or Denial of a Registration
Document Number: 2022-24425
Type: Rule
Date: 2022-11-14
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is amending its regulations by adding and revising provisions which enable DEA to hold registrants or applicants in default when they fail to timely request a hearing, or otherwise fail to participate in hearings. DEA is also amending its regulations to include an answer provision which will regulate how registrants respond to an Order to Show Cause (OTSC). These changes involve the revocation, suspension, or denial of a registration and do not affect other types of hearings.
Schedules of Controlled Substances: Placement of Ganaxolone in Schedule V
Document Number: 2022-24157
Type: Rule
Date: 2022-11-09
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 1, 2022, placing ganaxolone (3[alpha]-hydroxy-3[beta]-methyl-5[alpha]- pregnan-20-one) and its salts in schedule V of the Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains ganaxolone, including its salts, in schedule V of the Controlled Substances Act.
Specific Listing for 1-boc-4-AP, a Currently Controlled List I Chemical
Document Number: 2022-24155
Type: Rule
Date: 2022-11-09
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Chemical Control Number for tert-butyl 4- (phenylamino)piperidine-1-carboxylate (also known as 1-boc-4-AP; and CAS Number: 125541-22-2) and its salts as a list I chemical under the Controlled Substances Act. Although 1-boc-4-AP is not specifically listed as a list I chemical of the Controlled Substances Act with its own unique Chemical Control Number, it has been regulated as a list I chemical in the United States since May 15, 2020, as a carbamate of N- phenylpiperidin-4-amine, a list I chemical. Therefore, DEA is simply amending the list I chemicals list in its regulations to include a separate listing for 1-boc-4-AP, a currently controlled list I chemical.
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.; Correction
Document Number: 2022-24105
Type: Notice
Date: 2022-11-08
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published a document in the Federal Register on October 11, 2022, concerning a notice of application that inadvertently did not include the controlled substance Cocaine (9041).
Gerald M. Baltz, N.P.; Decision and Order
Document Number: 2022-24303
Type: Notice
Date: 2022-11-08
Agency: Drug Enforcement Administration, Department of Justice
George M. Douglass, M.D.; Decision and Order
Document Number: 2022-24301
Type: Notice
Date: 2022-11-08
Agency: Drug Enforcement Administration, Department of Justice
Nicky Shah, M.D.; Decision and Order
Document Number: 2022-24299
Type: Notice
Date: 2022-11-08
Agency: Drug Enforcement Administration, Department of Justice
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