Drug Enforcement Administration 2020 – Federal Register Recent Federal Regulation Documents

Importer of Controlled Substances Application: Yourway Transport
Document Number: 2020-28179
Type: Notice
Date: 2020-12-22
Agency: Drug Enforcement Administration, Department of Justice
Yourway Transport 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: Organic Standards Solutions International, LLC
Document Number: 2020-28178
Type: Notice
Date: 2020-12-22
Agency: Drug Enforcement Administration, Department of Justice
Organic Standards Solutions International, 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.
Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
Document Number: 2020-28177
Type: Notice
Date: 2020-12-22
Agency: Drug Enforcement Administration, Department of Justice
Fresenius Kabi USA, 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.
Designation of 3,4-MDP-2-P Methyl Glycidate (PMK Glycidate), 3,4-MDP-2-P Methyl Glycidic Acid (PMK Glycidic Acid), and Alpha-Phenylacetoacetamide (APAA) as List I Chemicals
Document Number: 2020-26813
Type: Proposed Rule
Date: 2020-12-21
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is proposing to designate 3,4-MDP-2-P methyl glycidate (PMK glycidate), including its optical and geometric isomers; 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), including its salts, optical and geometric isomers, and salts of isomers; and alpha-phenylacetoacetamide (APAA), including its optical isomers, as list I chemicals under the Controlled Substances Act (CSA). PMK glycidate and PMK glycidic acid are used in and are important to the manufacture of the schedule I controlled substance 3,4- methylenedioxymethamphetamine (MDMA) and other ``ecstasy''-type substances. APAA is used in and is important to the manufacture of the schedule II controlled substances amphetamine and methamphetamine. If finalized, this action would subject handlers (manufacturers, distributors, importers, and exporters) of PMK glycidate, PMK glycidic acid, and APAA to the chemical regulatory provisions of the CSA and its implementing regulations. This action does not propose the establishment of a threshold for domestic and international transactions of these chemicals. As such, all transactions involving any of these chemicals, regardless of size, would be regulated. In addition, this action proposes that chemical mixtures containing any of these three chemicals would not be exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of PMK glycidate, PMK glycidic acid, or APAA would be regulated.
Controls To Enhance the Cultivation of Marihuana for Research in the United States
Document Number: 2020-27999
Type: Rule
Date: 2020-12-18
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is amending its regulations to facilitate the cultivation of marihuana for research purposes and other licit purposes to enhance compliance with the Controlled Substances Act, including registering cultivators consistent with treaty obligations. This final rule adopts, with minor modifications, the notice of proposed rulemaking published on March 23, 2020, including regulations that govern applications by persons seeking to become registered with DEA to grow marihuana as bulk manufacturers, and regulations related to the purchase and sale of this marihuana by DEA.
Schedules of Controlled Substances: Exempt Anabolic Steroid Products
Document Number: 2020-25288
Type: Rule
Date: 2020-12-16
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is denying applications to designate four in-process preparations containing trenbolone acetate as exempt anabolic steroid products under the Controlled Substances Act.
Bulk Manufacturer of Controlled Substances Application: Sterling Wisconsin, LLC
Document Number: 2020-27512
Type: Notice
Date: 2020-12-15
Agency: Drug Enforcement Administration, Department of Justice
Sterling Wisconsin, 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: Adiramedica LLC
Document Number: 2020-27509
Type: Notice
Date: 2020-12-15
Agency: Drug Enforcement Administration, Department of Justice
Adiramedica LLC has applied to be registered as an importer of a basic class of a controlled substance. Refer to Supplemental Information listed below for further drug information.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc.
Document Number: 2020-27241
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
Johnson Matthey, 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: Sterling Pharma USA, LLC
Document Number: 2020-27240
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
Sterling Pharma USA, 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.
Lisa Hofschulz, N.P.; Decision and Order
Document Number: 2020-27239
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
George Pursley, M.D.; Denial of Application
Document Number: 2020-27236
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
Anindita Nandi, M.D.; Decision and Order
Document Number: 2020-27235
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
Poplar Grove Pharmacy Inc.;
Document Number: 2020-27234
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
Ernesto C. Torres, M.D.; Decision and Order
Document Number: 2020-27233
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
King Wong, M.D.; Decision and Order
Document Number: 2020-27232
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
Zeljko Stjepanovic, M.D.; Decision and Order
Document Number: 2020-27231
Type: Notice
Date: 2020-12-11
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Removal of Samidorphan From Control
Document Number: 2020-26812
Type: Proposed Rule
Date: 2020-12-10
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to remove samidorphan (3-carboxamido-4-hydroxy naltrexone) 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. Samidorphan 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 samidorphan.
Importer of Controlled Substances Application: Johnson Matthey Inc.
Document Number: 2020-26912
Type: Notice
Date: 2020-12-08
Agency: Drug Enforcement Administration, Department of Justice
Johnson Matthey 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.
Importer of Controlled Substances Application: Janssen Pharmaceuticals Inc.
Document Number: 2020-26653
Type: Notice
Date: 2020-12-04
Agency: Drug Enforcement Administration, Department of Justice
Janssen Pharmaceuticals 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.
Partial Filling of Prescriptions for Schedule II Controlled Substances
Document Number: 2020-26291
Type: Proposed Rule
Date: 2020-12-04
Agency: Drug Enforcement Administration, Department of Justice
On July 22, 2016, the Comprehensive Addiction and Recovery Act of 2016 became law. One provision of the Comprehensive Addiction and Recovery Act of 2016 amended the Controlled Substances Act to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions. The Drug Enforcement Administration is hereby proposing to amend its regulations to conform to this new statutory provision and to set forth the corresponding regulatory requirements.
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc.
Document Number: 2020-26651
Type: Notice
Date: 2020-12-03
Agency: Drug Enforcement Administration, Department of Justice
Janssen Pharmaceuticals 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.
Schedules of Controlled Substances: Temporary Placement of Brorphine in Schedule I
Document Number: 2020-26301
Type: Proposed Rule
Date: 2020-12-03
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule 1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)-1,3- dihydro-2H-benzo[d]imidazol-2-one (commonly known as brorphine), 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 of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the 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 brorphine.
Final Adjusted 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: 2020-26443
Type: Notice
Date: 2020-12-01
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the final adjusted 2020 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Established 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: 2020-26289
Type: Notice
Date: 2020-11-30
Agency: Drug Enforcement Administration, Department of Justice
This final order establishes the initial 2021 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Importer of Controlled Substances Application: Lyndra Therapeutics
Document Number: 2020-26175
Type: Notice
Date: 2020-11-27
Agency: Drug Enforcement Administration, Department of Justice
Lyndra Therapeutics 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: Noramco Inc.
Document Number: 2020-26174
Type: Notice
Date: 2020-11-27
Agency: Drug Enforcement Administration, Department of Justice
Noramco 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.
Importer of Controlled Substances Application: Meridian Medical Technologies
Document Number: 2020-26172
Type: Notice
Date: 2020-11-27
Agency: Drug Enforcement Administration, Department of Justice
Meridian Medical Technologies 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: Novitium Pharma LLC
Document Number: 2020-26171
Type: Notice
Date: 2020-11-27
Agency: Drug Enforcement Administration, Department of Justice
Novitium 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.
Schedules of Controlled Substances: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl in Schedule I
Document Number: 2020-22757
Type: Rule
Date: 2020-11-25
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration places cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N- (1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide), including their 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 of the Controlled Substances Act. This action continues the imposition of 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 cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para- methoxybutyryl fentanyl, and valeryl fentanyl.
Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc.
Document Number: 2020-25764
Type: Notice
Date: 2020-11-23
Agency: Drug Enforcement Administration, Department of Justice
Johnson Matthey Pharmaceutical Materials 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.
Julie I. Dee, M.D.; Decision and Order
Document Number: 2020-25534
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
ECO Apothecary, LLC; Decision and Order
Document Number: 2020-25533
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Suntree Pharmacy and Suntree Medical Equipment, LLC; Decision and Order
Document Number: 2020-25531
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Monica Ferguson, F.N.P., R.N.; Decision and Order
Document Number: 2020-25529
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Jeanne E. Germeil, M.D. Decision and Order
Document Number: 2020-25528
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Hil Rizvi, M.D.; Decision and Order
Document Number: 2020-25527
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Jeffrey M. Wolk, M.D.; Decision and Order
Document Number: 2020-25526
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Jonathan Rosenfield, M.D.; Decision and Order
Document Number: 2020-25524
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Verne A. Schwager, M.D.; Decision and Order
Document Number: 2020-25523
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Lewis Leavitt III, M.D.; Decision and Order
Document Number: 2020-25521
Type: Notice
Date: 2020-11-19
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2020-24466
Type: Notice
Date: 2020-11-04
Agency: Drug Enforcement Administration, Department of Justice
Cerilliant Corporation 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: Navinta LLC
Document Number: 2020-24465
Type: Notice
Date: 2020-11-04
Agency: Drug Enforcement Administration, Department of Justice
Navinta 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 Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment
Document Number: 2020-23813
Type: Rule
Date: 2020-11-02
Agency: Drug Enforcement Administration, Department of Justice
The ``Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (the SUPPORT Act),'' which became law on October 24, 2018, amended the Controlled Substances Act to expand the conditions a practitioner must meet to provide medication-assisted treatment and expand the options available for a physician to be considered a qualifying physician. The SUPPORT Act removed the time period for a nurse practitioner or physician assistant to be considered a qualifying other practitioner, and revised the definition of a qualifying practitioner. The SUPPORT Act also allows a pharmacy to deliver prescribed controlled substances to a practitioner's registered location for the purpose of maintenance or detoxification treatment to be administered under certain conditions by a practitioner. The Drug Enforcement Administration amends its regulations to make them consistent with the SUPPORT Act and implement its requirements.
Suspicious Orders of Controlled Substances
Document Number: 2020-21302
Type: Proposed Rule
Date: 2020-11-02
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is proposing to revise its regulations relating to suspicious orders of controlled substances, in order to implement the Preventing Drug Diversion Act of 2018 (PDDA) and to clarify the procedures a registrant must follow for orders received under suspicious circumstances (ORUSCs). Upon receipt of an ORUSC, registrants authorized to distribute controlled substances would have a choice of proceeding under one of two options (the ``two option framework''). In addition, these registrants would be required to submit all suspicious order reports to a DEA centralized database, and keep records pertaining to suspicious orders and ORUSCs.
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.