Drug Enforcement Administration November 2022 – Federal Register Recent Federal Regulation Documents

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
Technical Correction to Regulation Regarding Registration Exception for Officials
Document Number: 2022-24140
Type: Rule
Date: 2022-11-07
Agency: Drug Enforcement Administration, Department of Justice
This final rule updates a Drug Enforcement Administration regulation involving exemption from registration for law enforcement officials by removing an inapposite cross-reference listing. This action makes no substantive changes to this regulation.
Bulk Manufacturer of Controlled Substances Application: Organix Chemistry Solutions LLC
Document Number: 2022-24103
Type: Notice
Date: 2022-11-04
Agency: Drug Enforcement Administration, Department of Justice
Organix Chemistry Solutions 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.
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