Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Bulk Manufacturer of Controlled Substances Applications: Bulk Manufacturers of Marihuana; Correction
Document Number: 2019-22312
Type: Notice
Date: 2019-10-11
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) published a document in the Federal Register on August 27, 2019, concerning a notice of applications. As that document correctly indicated, each of the applicants noticed applied to be registered with DEA to grow marihuana as a bulk manufacturer. However, certain drug codes for some of the applicants were inadvertently omitted by DEA or not listed because applicants had inadvertently omitted them from their applications.
Importer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc.
Document Number: 2019-21829
Type: Notice
Date: 2019-10-07
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-21321
Type: Notice
Date: 2019-10-01
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 Application: Noramco Inc.
Document Number: 2019-21320
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Noramco, Inc.
Document Number: 2019-21319
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration; Siemens Healthcare Diagnostics, Inc.
Document Number: 2019-21313
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have 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 Registration
Document Number: 2019-21312
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
The registrants listed below have applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: CreaGen Inc.
Document Number: 2019-21311
Type: Notice
Date: 2019-10-01
Agency: Drug Enforcement Administration, Department of Justice
New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222)
Document Number: 2019-21021
Type: Rule
Date: 2019-09-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is amending its regulations to implement a new single-sheet format for DEA Form 222, used by DEA registrants to order schedules I and II controlled substances. The rule provides for a two-year transition period, during which the existing triplicate version of the forms may continue to be used. The rule also includes a number of minor procedural changes.
John Yolman Salinas, M.D.; Decision and Order
Document Number: 2019-20420
Type: Notice
Date: 2019-09-20
Agency: Drug Enforcement Administration, Department of Justice
Peter J. Waidzunas, D.D.S.; Decision and Order
Document Number: 2019-20418
Type: Notice
Date: 2019-09-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Globyz Pharma, LLC
Document Number: 2019-20417
Type: Notice
Date: 2019-09-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Registration
Document Number: 2019-20416
Type: Notice
Date: 2019-09-20
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 Application: Fisher Clinical Services, Inc.
Document Number: 2019-20414
Type: Notice
Date: 2019-09-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2019-20413
Type: Notice
Date: 2019-09-20
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Galephar Pharmaceutical Research Inc.
Document Number: 2019-20412
Type: Notice
Date: 2019-09-20
Agency: Drug Enforcement Administration, Department of Justice
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.