Drug Enforcement Administration October 2019 – Federal Register Recent Federal Regulation Documents

Schedules of Controlled Substances: Placement of FUB-AMB in Schedule I
Document Number: 2019-23626
Type: Proposed Rule
Date: 2019-10-30
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing methyl 2- (1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutano ate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its salts, isomers, 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. 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, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle FUB-AMB.
Schedules of Controlled Substances: Extension of Temporary Placement of FUB-AMB in Schedule I of the Controlled Substances Act
Document Number: 2019-23372
Type: Rule
Date: 2019-10-30
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, methyl 2-(1-(4- fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of FUB-AMB currently is in effect until November 4, 2019. This temporary order will extend the temporary scheduling of FUB- AMB for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
Lesly Pompy, M.D.; Decision and Order
Document Number: 2019-23503
Type: Notice
Date: 2019-10-28
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Catalent CTS, LLC
Document Number: 2019-23502
Type: Notice
Date: 2019-10-28
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2019-23501
Type: Notice
Date: 2019-10-28
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 Registration
Document Number: 2019-23500
Type: Notice
Date: 2019-10-28
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 various classes of schedule I and II controlled substances.
Bulk Manufacturer of Controlled Substances Application: Euticals Inc.
Document Number: 2019-23499
Type: Notice
Date: 2019-10-28
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Placement of Cyclopropyl Fentanyl, Methoxyacetyl fentanyl, ortho-Fluorofentanyl, and para-Fluorobutyryl Fentanyl in Schedule I
Document Number: 2019-23348
Type: Rule
Date: 2019-10-25
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration maintains the placement of the substances cyclopropyl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide), methoxyacetyl fentanyl (2-methoxy-N-(1-phenethylpiperidin-4-yl)-N- phenylacetamide), ortho-fluorofentanyl (N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)propionamide), and para-fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States' obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose 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 or conduct instructional activities with, or possess), or propose to handle, cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho- fluorofentanyl, and para-fluorobutyryl fentanyl.
Management of Quotas for Controlled Substances and List I Chemicals
Document Number: 2019-21989
Type: Proposed Rule
Date: 2019-10-23
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to revise existing regulations that manage the quotas for controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, held by DEA-registered manufacturers. This rule is being proposed to: Define the types of quotas, update the method to abandon quota, clarify the current language to ensure that both manufacturers and distributors are required to obtain certification of a buyer's quota, reduce overall inventories, formalize the existing practice of use-specific subcategories for individual manufacturing and procurement quotas, and modify existing deadlines to fix/issue quotas. The DEA is also amending certain regulations to implement updates to the Controlled Substances Act made by the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act. The DEA emphasizes that all of these revisions and amendments would apply to both bulk and dosage-form manufacturers, as well as importers of the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The changes are necessary to reduce the potential for diversion, and would align regulations with current manufacturing business practices.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc.
Document Number: 2019-23012
Type: Notice
Date: 2019-10-22
Agency: Drug Enforcement Administration, Department of Justice
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
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