Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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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.
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.