Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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Schedules of Controlled Substances: Placement of Oliceridine in Schedule II
Document Number: 2020-22762
Type: Rule
Date: 2020-10-30
Agency: Drug Enforcement Administration, Department of Justice
On August 7, 2020, the U.S. Food and Drug Administration approved a new drug application for oliceridine, chemically known as N- [(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl{time} )amine fumarate. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place oliceridine in schedule II 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 oliceridine, 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, in schedule II of the CSA.
Implementation of the Combat Methamphetamine Epidemic Act of 2005; Retail Sales; Notice of Transfers Following Importation or Exportation
Document Number: 2020-19311
Type: Rule
Date: 2020-10-29
Agency: Drug Enforcement Administration, Department of Justice
In March 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA). The Drug Enforcement Administration (DEA) promulgated an Interim Final Rule (IFR) on September 26, 2006 (with a technical correction on October 13, 2006), under Docket Number DEA- 291I, to implement the retail sales provisions of the CMEA. Additionally, on April 9, 2007, DEA promulgated an IFR, under Docket Number DEA-292I, to implement section 716 of the CMEA, which required additional reporting for import, export, and international transactions involving all list I and list II chemicals. DEA is finalizing these rulemakings in one action. This final rule adopts, with one technical change, the corrected September 2006 IFR, and adopts, without change, the April 2007 IFR.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Contract Pharmacal Corp.
Document Number: 2020-23845
Type: Notice
Date: 2020-10-28
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 proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: API GLOBAL LLC
Document Number: 2020-23767
Type: Notice
Date: 2020-10-27
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 proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration.
Importer of Controlled Substances Application: Mylan Pharmaceuticals
Document Number: 2020-23766
Type: Notice
Date: 2020-10-27
Agency: Drug Enforcement Administration, Department of Justice
Mylan Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Mylan Technologies Inc.
Document Number: 2020-23511
Type: Notice
Date: 2020-10-23
Agency: Drug Enforcement Administration, Department of Justice
Mylan Technologies Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Noramco Inc.
Document Number: 2020-23396
Type: Notice
Date: 2020-10-22
Agency: Drug Enforcement Administration, Department of Justice
Noramco Inc. 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.
Bulk Manufacturer of Controlled Substances Application: Kinetochem LLC
Document Number: 2020-23395
Type: Notice
Date: 2020-10-22
Agency: Drug Enforcement Administration, Department of Justice
Kinetochem 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.
Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008; Correction
Document Number: 2020-22761
Type: Rule
Date: 2020-10-22
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is correcting a final rule that published in the Federal Register on September 30, 2020. The final rule implemented the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. This change will provide clarity.
Bulk Manufacturer of Controlled Substances Application: Euticals, Inc.
Document Number: 2020-22692
Type: Notice
Date: 2020-10-14
Agency: Drug Enforcement Administration, Department of Justice
Euticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Synthcon, LLC
Document Number: 2020-22690
Type: Notice
Date: 2020-10-14
Agency: Drug Enforcement Administration, Department of Justice
Synthcon, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
Document Number: 2020-22442
Type: Notice
Date: 2020-10-09
Agency: Drug Enforcement Administration, Department of Justice
Purisys, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Steven A. Holper, M.D.; Decision and Order
Document Number: 2020-22390
Type: Notice
Date: 2020-10-09
Agency: Drug Enforcement Administration, Department of Justice
Wayne Pharmacy; Decision and Order
Document Number: 2020-22216
Type: Notice
Date: 2020-10-08
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: MMJ Biopharma Cultivation, Inc.
Document Number: 2020-22070
Type: Notice
Date: 2020-10-08
Agency: Drug Enforcement Administration, Department of Justice
Barbara D. Marino, M.D.; Decision and Order
Document Number: 2020-22214
Type: Notice
Date: 2020-10-07
Agency: Drug Enforcement Administration, Department of Justice
Jacqueline G. Curtis, M.D.; Decision and Order
Document Number: 2020-22213
Type: Notice
Date: 2020-10-07
Agency: Drug Enforcement Administration, Department of Justice
Stacey Lynne Schirmer, M.D.; Decision and Order
Document Number: 2020-22210
Type: Notice
Date: 2020-10-07
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
Document Number: 2020-22076
Type: Notice
Date: 2020-10-06
Agency: Drug Enforcement Administration, Department of Justice
Halo Pharmaceutical, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: S&B Pharma, LLC
Document Number: 2020-22075
Type: Notice
Date: 2020-10-06
Agency: Drug Enforcement Administration, Department of Justice
S&B Pharma, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Wildlife Laboratories, LLC
Document Number: 2020-22069
Type: Notice
Date: 2020-10-06
Agency: Drug Enforcement Administration, Department of Justice
Wildlife Laboratories, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Eli Elsohly Laboratories
Document Number: 2020-22068
Type: Notice
Date: 2020-10-06
Agency: Drug Enforcement Administration, Department of Justice
Eli Elsohly Laboratories has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Schedules of Controlled Substances: Placement of Remimazolam in Schedule IV
Document Number: 2020-19313
Type: Rule
Date: 2020-10-06
Agency: Drug Enforcement Administration, Department of Justice
On July 2, 2020, the U.S. Food and Drug Administration approved a new drug application for BYFAVO (remimazolam) for intravenous use. Remimazolam is chemically known as 4H-imidazol[1,2- a][1,4]benzodiazepine-4-propionic acid, 8-bromo-1-methyl-6-(2- pyridinyl)-(4S)-methyl ester, benzenesulfonate (1:1) and also, methyl 3-[(4S)-8-bromo-1-methyl-6-pyridin-2-yl-4H-imidazo[1,2- a][1,4]benzodiazepin-4yl]propanoate benzenesulfonic acid. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place remimazolam and its salts in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing remimazolam, 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.
Registering Emergency Medical Services Agencies Under the Protecting Patient Access to Emergency Medications Act of 2017
Document Number: 2020-21675
Type: Proposed Rule
Date: 2020-10-05
Agency: Drug Enforcement Administration, Department of Justice
The ``Protecting Patient Access to Emergency Medications Act of 2017,'' (hereafter the ``Act'') which became law on November 17, 2017, amended the Controlled Substances Act to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances. In addition, the Act allows emergency medical services professionals to administer controlled substances outside the physical presence of a medical director or authorizing medical professional pursuant to a valid standing or verbal order. The Drug Enforcement Administration proposes to amend its regulations to make them consistent with the Act and to otherwise implement its requirements.
Schedules of Controlled Substances: Placement of Crotonyl Fentanyl in Schedule I
Document Number: 2020-19305
Type: Rule
Date: 2020-10-02
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 crotonyl fentanyl ((E)-N-(1-phenethylpiperidin-4-yl)-N- phenylbut-2-enamide), including its 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 crotonyl fentanyl.
Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Document Number: 2020-21310
Type: Rule
Date: 2020-09-30
Agency: Drug Enforcement Administration, Department of Justice
On April 6, 2009, the Drug Enforcement Administration published the interim final rule titled ``Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008,'' which amended DEA's regulations by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet. This action adopts the interim final rule as a final rule without change, apart from a minor technical amendment and certain changes to DEA regulations already made by intervening rules. This action also reinstates amendments that were inadvertently removed by the Controlled Substances and List I Chemical Registration and Reregistration Fees final rule published on March 15, 2012.
Default Provisions for Hearing Proceedings Relating to the Revocation, Suspension, or Denial of a DEA Registration
Document Number: 2020-19309
Type: Proposed Rule
Date: 2020-09-30
Agency: Drug Enforcement Administration, Department of Justice
This proposed rulemaking would add provisions requiring a person served with an order to show cause issued pursuant to the Controlled Substances Act to file a request for a hearing no later than 15 days after the date of receipt of the order. The proposed rulemaking would also add provisions requiring that a person who requests a hearing file an answer to the order to show cause no later than 30 days after the date of receipt of the order; it also sets forth criteria for what the answer must contain. The proposed rule would add provisions allowing the entry of a default where a party served with an order to show cause fails to request a hearing, fails to file an answer to the order to show cause, or otherwise fails to defend against the order to show cause. The proposed rule provides that where a party defaults, the factual allegations of the order to show cause would be deemed admitted. The proposed rule would also provide for the dismissal of an order to show cause where the Administration fails to prosecute the proceeding. This proposed rule would also provide that a default may only be excused upon a party establishing good cause to excuse its default and sets forth the procedures a party must follow to seek such relief. Further, the proposed rule would remove the current provisions allowing a recipient of an order to show cause to file a written statement while waiving his/her/its right to an administrative hearing.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2020-21083
Type: Notice
Date: 2020-09-24
Agency: Drug Enforcement Administration, Department of Justice
Fisher Clinical Services, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Importer of Controlled Substances Application: Caligor Coghlan Pharma Services
Document Number: 2020-21009
Type: Notice
Date: 2020-09-23
Agency: Drug Enforcement Administration, Department of Justice
Caligor Coghlan Pharma Services has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Organix Inc.
Document Number: 2020-20162
Type: Notice
Date: 2020-09-14
Agency: Drug Enforcement Administration, Department of Justice
Organix Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Novitium Pharma LLC
Document Number: 2020-20161
Type: Notice
Date: 2020-09-14
Agency: Drug Enforcement Administration, Department of Justice
Novitium Pharma LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug(s) information.
Bulk Manufacturer of Controlled Substances Application: Cambridge Isotype Lab
Document Number: 2020-20160
Type: Notice
Date: 2020-09-14
Agency: Drug Enforcement Administration, Department of Justice
Cambridge Isotype Lab has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug(s) information.
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2020-20159
Type: Notice
Date: 2020-09-14
Agency: Drug Enforcement Administration, Department of Justice
Cerilliant Corporation has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Reinstatement of a Previously Approved Collection: Drug Questionnaire (DEA-341)
Document Number: 2020-19924
Type: Notice
Date: 2020-09-09
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration, Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Bulk Manufacturer of Controlled Substances Application: Nanosyn Inc.
Document Number: 2020-19868
Type: Notice
Date: 2020-09-09
Agency: Drug Enforcement Administration, Department of Justice
Nanosyn Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substances. Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Cambridge Isotope Laboratories
Document Number: 2020-19806
Type: Notice
Date: 2020-09-08
Agency: Drug Enforcement Administration, Department of Justice
Cambridge Isotope Laboratories has applied to be registered as an importer of basic class(es) of controlled substances. Refer to Supplemental Information listed below for further drugs information.
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2020-19805
Type: Notice
Date: 2020-09-08
Agency: Drug Enforcement Administration, Department of Justice
Cayman Chemical Company has applied to be registered as a bulk manufacturer of basic class(es) controlled substances. Refer to Supplemental Information listed below for further drug information.
Importer of Controlled Substances Application: Aspen API, Inc.
Document Number: 2020-19804
Type: Notice
Date: 2020-09-08
Agency: Drug Enforcement Administration, Department of Justice
Aspen API, Inc. has applied to be registered as an importer of basic class(es) of controlled substance. Refer to Supplemental Information listed below for further drug information.
Proposed Adjustments to the 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: 2020-19308
Type: Notice
Date: 2020-09-01
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes to adjust the 2020 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
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 2021
Document Number: 2020-19285
Type: Notice
Date: 2020-09-01
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to establish the 2021 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.
Heavenly Care Pharmacy; Decision and Order
Document Number: 2020-18975
Type: Notice
Date: 2020-08-28
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Extension of Temporary Placement of N-Ethylpentylone in Schedule I of the Controlled Substances Act
Document Number: 2020-19011
Type: Rule
Date: 2020-08-27
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this order to extend the temporary schedule I status of a synthetic cathinone, 1-(1,3-benzodioxol-5-yl)-2- (ethylamino)pentan-1-one (N-ethylpentylone, ephylone), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of N-ethylpentylone currently is in effect until August 31, 2020. This order extends the temporary scheduling of N- ethylpentylone for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
Schedules of Controlled Substances: Placement of N-Ethylpentylone in Schedule I
Document Number: 2020-19007
Type: Proposed Rule
Date: 2020-08-27
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration proposes placing 1-(1,3- benzodioxol-5-yl)-2-(ethylamino)pentan-1-one (N-ethylpentylone, ephylone) and its optical, positional, and geometric isomers, salts, 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, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle N-ethylpentylone.
Implementation of the Agriculture Improvement Act of 2018
Document Number: 2020-17356
Type: Rule
Date: 2020-08-21
Agency: Drug Enforcement Administration, Department of Justice
The purpose of this interim final rule is to codify in the Drug Enforcement Administration (DEA) regulations the statutory amendments to the Controlled Substances Act (CSA) made by the Agriculture Improvement Act of 2018 (AIA), regarding the scope of regulatory controls over marihuana, tetrahydrocannabinols, and other marihuana-related constituents. This interim final rule merely conforms DEA's regulations to the statutory amendments to the CSA that have already taken effect, and it does not add additional requirements to the regulations.
Schedules of Controlled Substances: Temporary Placement of Isotonitazene in Schedule I
Document Number: 2020-17951
Type: Rule
Date: 2020-08-20
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary order to schedule N,N-diethyl- 2-(2-(4 isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine (commonly known as isotonitazene), 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, in schedule I. This action is based on a finding by the Acting Administrator that the placement of isotonitazene 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, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle isotonitazene.
Schedules of Controlled Substances: Placement of Cenobamate in Schedule V
Document Number: 2020-17357
Type: Rule
Date: 2020-08-20
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 March 10, 2020, placing cenobamate [(1R)-1-(2-chlorophenyl)-2-(tetrazol-2- yl)ethyl] carbamate, including its salts, in schedule V of the Controlled Substances Act (CSA). With the issuance of this final rule, the Drug Enforcement Administration maintains cenobamate, including its salts, in schedule V of the CSA.
Morning Star Pharmacy & Medical Supply 1; Decision And Order
Document Number: 2020-18083
Type: Notice
Date: 2020-08-19
Agency: Drug Enforcement Administration, Department of Justice
David Mwebe, M.D.; Decision and Order
Document Number: 2020-18082
Type: Notice
Date: 2020-08-19
Agency: Drug Enforcement Administration, Department of Justice
Mark D. Beale, M.D.; Decision and Order
Document Number: 2020-17448
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
Document Number: 2020-17438
Type: Notice
Date: 2020-08-11
Agency: Drug Enforcement Administration, Department of Justice
Purisys, LLC applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Lysergic acid diethylamide and Pentobarbital.