Drug Enforcement Administration October 2020 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.