Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Listing of Noroxymorphone in the Code of Federal Regulations and Assignment of a Controlled Substances Code Number
Document Number: 2019-17623
Type: Rule
Date: 2019-08-16
Agency: Drug Enforcement Administration, Department of Justice
Noroxymorphone is a derivative of opium and opiates and, as such, is a schedule II controlled substance. The Drug Enforcement Administration (DEA) has established the use of the Drug Enforcement Administration Code Number 9668 for tracking noroxymorphone and for establishing aggregate production quotas. This rule amends the Code of Federal Regulations (CFR) to reflect the current practice of using the Code Number 9668 for noroxymorphone. This rulemaking will list the schedule II controlled substance noroxymorphone as a basic class with the Code Number 9668. This rule does not affect the control of noroxymorphone as a schedule II controlled substance.
Brent E. Silvers, M.D.; Decision and Order
Document Number: 2019-17622
Type: Notice
Date: 2019-08-16
Agency: Drug Enforcement Administration, Department of Justice
Peter John Ulbrich, M.D.; Decision and Order
Document Number: 2019-17621
Type: Notice
Date: 2019-08-16
Agency: Drug Enforcement Administration, Department of Justice
Parth S. Bharill; Decision and Order
Document Number: 2019-17004
Type: Notice
Date: 2019-08-08
Agency: Drug Enforcement Administration, Department of Justice
Anthony Schapera, M.D.; Decision and Order
Document Number: 2019-17003
Type: Notice
Date: 2019-08-08
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation
Document Number: 2019-17002
Type: Notice
Date: 2019-08-08
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC
Document Number: 2019-16177
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Document Number: 2019-16176
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
Document Number: 2019-16175
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex Charles City
Document Number: 2019-16174
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Nostrum Laboratories, Inc.
Document Number: 2019-16173
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Chattem Chemicals
Document Number: 2019-16172
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-16169
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I or schedule II controlled substances.
Importer of Controlled Substances Application: Xcelience
Document Number: 2019-16168
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Research Triangle Institute
Document Number: 2019-16167
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
Document Number: 2019-16166
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Southern Ohio Correctional Facility
Document Number: 2019-16165
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Alcami Carolinas Corporation
Document Number: 2019-16164
Type: Notice
Date: 2019-07-30
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Restek Corporation
Document Number: 2019-15738
Type: Notice
Date: 2019-07-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2019-15737
Type: Notice
Date: 2019-07-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cardinal Health
Document Number: 2019-15728
Type: Notice
Date: 2019-07-24
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of N
Document Number: 2019-15184
Type: Rule
Date: 2019-07-18
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration (DEA) is issuing this temporary scheduling order to schedule the synthetic cathinones, N-ethylhexedrone (2-(ethylamino)-1- phenylhexan-1-one); alpha-pyrrolidinohexanophenone (1-phenyl-2- (pyrrolidin-1-yl)hexan-1-one; alpha-pyrrolidinohexiophenone; trivial name: [alpha]-PHP); 4-methyl-alpha-ethylaminopentiophenone (2- (ethylamino)-1-(4-methylphenyl)pentan-1-one; trivial name: 4-MEAP); 4'- methyl-alpha-pyrrolidinohexiophenone (1-(4-methylphenyl)-2-(pyrrolidin- 1-yl)hexan-1-one; 4'-methyl-alpha-pyrrolidinohexanophenone; trivial name: MPHP); alpha-pyrrolidinoheptaphenone (1-phenyl-2-(pyrrolidin-1- yl)heptan-1-one; trivial name: PV8); and 4'-chloro-alpha- pyrrolidinovalerophenone (1-(4-chlorophenyl)-2-(pyrrolidin-1-yl)pentan- 1-one; 4'-chloro-alpha-pyrrolidinopentiophenone; trivial name: 4- chloro-[alpha]-PVP), and their optical, positional, and geometric isomers, salts, and salts of isomers in schedule I. This action is based on a finding by the Acting Administrator that the placement of these synthetic cathinones in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, possess, import, export, research, or conduct instructional activities or chemical analysis), or propose to handle, N-ethylhexedrone, [alpha]-PHP, 4-MEAP, MPHP, PV8, and 4-chloro- [alpha]-PVP.
Bulk Manufacturer of Controlled Substances Application: Absolute Standards, Inc.
Document Number: 2019-14029
Type: Notice
Date: 2019-07-02
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories, Inc.
Document Number: 2019-14028
Type: Notice
Date: 2019-07-02
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Bellwyck Clinical Services
Document Number: 2019-14027
Type: Notice
Date: 2019-07-02
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Lipomed
Document Number: 2019-14026
Type: Notice
Date: 2019-07-02
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma Aldrich Co., LLC
Document Number: 2019-14025
Type: Notice
Date: 2019-07-02
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-14023
Type: Notice
Date: 2019-07-02
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted registration by the Drug Enforcement Administration (DEA) as importer of schedule I controlled substances.
Importer of Controlled Substances Application: VHG Labs DBA LGC Standards
Document Number: 2019-13377
Type: Notice
Date: 2019-06-24
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Thiafentanil in Schedule II
Document Number: 2019-12735
Type: Rule
Date: 2019-06-18
Agency: Drug Enforcement Administration, Department of Justice
On August 26, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register an interim final rule with request for comments placing the substance thiafentanil, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers, in schedule II of the Controlled Substances Act. This final rule adopts that interim final rule without change.
Importer of Controlled Substances Registration
Document Number: 2019-12740
Type: Notice
Date: 2019-06-17
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as an importer of schedule I controlled substances.
Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV
Document Number: 2019-12723
Type: Rule
Date: 2019-06-17
Agency: Drug Enforcement Administration, Department of Justice
On March 20, 2019, the U.S. Food and Drug Administration approved a new drug application for SUNOSI, a drug product consisting of solriamfetol ((R)-2-amino-3-phenylpropyl carbamate hydrochloride) tablets for oral use. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place solriamfetol in schedule IV 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 solriamfetol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.
Schedules of Controlled Substances: Placement of Brexanolone in Schedule IV
Document Number: 2019-12721
Type: Rule
Date: 2019-06-17
Agency: Drug Enforcement Administration, Department of Justice
On March 19, 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application for Zulresso (brexanolone). Brexanolone is chemically known as 3[alpha]-hydroxy-5[alpha]-pregnan-20-one and is also referred to as allopregnanolone. The Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a recommendation that brexanolone be placed in schedule IV 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 brexanolone (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.
Elizabeth C. Korcz, M.D.; Decision and Order
Document Number: 2019-12506
Type: Notice
Date: 2019-06-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories
Document Number: 2019-12505
Type: Notice
Date: 2019-06-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-12504
Type: Notice
Date: 2019-06-13
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a basic class of schedule II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research
Document Number: 2019-12503
Type: Notice
Date: 2019-06-13
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-11881
Type: Notice
Date: 2019-06-06
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chem
Document Number: 2019-11878
Type: Notice
Date: 2019-06-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: SpecGx LLC
Document Number: 2019-11877
Type: Notice
Date: 2019-06-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Shertech Laboratories, LLC
Document Number: 2019-11876
Type: Notice
Date: 2019-06-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-10669
Type: Notice
Date: 2019-05-22
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and schedule II controlled substances.
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2019-10668
Type: Notice
Date: 2019-05-22
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Wildlife Laboratories, Inc.
Document Number: 2019-10030
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-10028
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and schedule II controlled substances.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-10026
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-10025
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below has applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various classes of schedule I controlled substances.
Fred J. Powell, M.D.; Decision and Order
Document Number: 2019-10019
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Raquel Skidmore, M.D.; Decision and Order
Document Number: 2019-10015
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-10014
Type: Notice
Date: 2019-05-15
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of schedule I and II controlled substances.