Drug Enforcement Administration March 2023 – Federal Register Recent Federal Regulation Documents

Purisys, 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.

Sterling Pharma USA 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.

Myonex 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.

Patheon Pharmaceuticals 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.

Lonza Tampa, LLC 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.

Caligor Coghlan Pharma Services 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.

Scottsdale Research Institute 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.

With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing 1-(1-(1-(4- bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-benzo[d]imid azol-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 within the specific chemical designation, 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 brorphine.

The Drug Enforcement Administration (DEA) is amending its regulations, in concert with the Department of Health and Human Services (HHS), to expand the circumstances under which individual practitioners are authorized to prescribe schedule III-V narcotic drugs or combinations of such drugs that have been approved for use in continuous medical treatment (also referred to as maintenance) or withdrawal management treatment (also referred to as detoxification) via a telemedicine encounter, including an audio-only telemedicine encounter.