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: 2019-19786
Type: Proposed Rule
Date: 2019-09-17
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to designate the precursor chemical, N-phenyl-N-(piperidin-4- yl)propionamide (norfentanyl) as an immediate precursor for the schedule II controlled substance fentanyl. Furthermore, the DEA proposes to control norfentanyl as a schedule II substance under the Controlled Substances Act (CSA). Norfentanyl is the immediate chemical intermediary in a synthesis process currently used by clandestine laboratory operators for the illicit manufacture of the schedule II controlled substance fentanyl. The distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of thousands of fentanyl-related overdoses in the United States in recent years. The DEA believes that the control of norfentanyl as a schedule II controlled substance is necessary to prevent its diversion as an immediate chemical intermediary for the illicit production of fentanyl.
Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as List I Chemicals
Document Number: 2019-19787
Type: Proposed Rule
Date: 2019-09-13
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is proposing the control 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). Benzylfentanyl and 4-anilinopiperidine are used in, and are important to, the illicit manufacture of the schedule II controlled substance fentanyl. If finalized, this action would subject handlers of benzylfentanyl and 4-anilinopiperidine to the chemical regulatory provisions of the CSA and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of benzylfentanyl or 4-anilinopiperidine. As such, all transactions of chemical mixtures containing benzylfentanyl or 4- anilinopiperidine will be regulated at any concentration and will be subject to control under the CSA.
Proposed 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 2020
Document Number: 2019-19785
Type: Notice
Date: 2019-09-12
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to establish the 2020 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Jeffrey Stein, M.D.; Decision and Order
Document Number: 2019-19305
Type: Notice
Date: 2019-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-18688
Type: Notice
Date: 2019-08-29
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 II controlled substances.
Importer of Controlled Substances Registration
Document Number: 2019-18687
Type: Notice
Date: 2019-08-29
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for ad been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and II controlled substances.
Importer of Controlled Substances Registration
Document Number: 2019-18686
Type: Notice
Date: 2019-08-29
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 II controlled substances.
Importer of Controlled Substances Registration
Document Number: 2019-18685
Type: Notice
Date: 2019-08-29
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 II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2019-18681
Type: Notice
Date: 2019-08-29
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Applications: Bulk Manufacturers of Marihuana
Document Number: 2019-18456
Type: Notice
Date: 2019-08-27
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is providing notice of certain applications it has received from entities applying to be registered to manufacture in bulk a basic class of controlled substances listed in schedule I. Prior to making decisions on these pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration. In addition, this notice informs applicants that they may withdraw their applications if they no longer need to obtain a registration because of the recent amendments made by the Agriculture Improvement Act of 2018 to the definition of marihuana to no longer include ``hemp'' as defined by law.
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2019-18455
Type: Notice
Date: 2019-08-27
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Nanosyn, Inc
Document Number: 2019-18454
Type: Notice
Date: 2019-08-27
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Akorn, Inc.
Document Number: 2019-18453
Type: Notice
Date: 2019-08-27
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration AMPAC Fine Chemicals Virginia, LLC
Document Number: 2019-18325
Type: Notice
Date: 2019-08-26
Agency: Drug Enforcement Administration, Department of Justice
The registrant listed below have applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of various basic classes of schedule II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc.
Document Number: 2019-18324
Type: Notice
Date: 2019-08-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMRI Renesselaer, Inc.
Document Number: 2019-18323
Type: Notice
Date: 2019-08-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2019-18322
Type: Notice
Date: 2019-08-26
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cambrex High Point, Inc.
Document Number: 2019-18321
Type: Notice
Date: 2019-08-26
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Clinical Supplies Management Holdings, Inc.
Document Number: 2019-18320
Type: Notice
Date: 2019-08-26
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Removal of 6β-naltrexol From Control
Document Number: 2019-17630
Type: Proposed Rule
Date: 2019-08-21
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to remove (5[alpha],6[beta])-17-(cyclopropylmethyl)-4,5-epoxymorphinan- 3,6,14- triol (6[beta]-naltrexol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. 6[beta]-Naltrexol is currently a schedule II controlled substance because it can be derived from opium alkaloids. This action would remove 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, conduct research, import, export, or conduct chemical analysis) or propose to handle 6[beta]-naltrexol.
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.