Drug Enforcement Administration 2021 – Federal Register Recent Federal Regulation Documents

Noramco, 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.

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.

The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule seven synthetic benzimidazole-opioid substances, 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. 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 these seven specified controlled substances.

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.

This final order establishes the initial 2022 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.

Patheon API Manufacturing, 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.

Noramco, 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 (DEA) is issuing this advanced notice of proposed rulemaking to obtain further information regarding the practice of telepharmacy. Telepharmacy is not specifically defined by the Controlled Substances Act (CSA) or DEA regulations; however, to the extent telepharmacies dispense controlled substances, they are under the purview of the CSA and DEA. DEA is considering promulgating regulations regarding telepharmacy and seeks to be fully informed about the practice, industry, and state regulation of telepharmacy.

The Drug Enforcement Administration proposes to remove [\18\F]FP-CIT (chemical names: [\18\F]N-[omega]-fluoropropyl-[beta]- CIT; fluorine-18-N-3-fluoropropyl-2-beta-carbomethoxy-3-beta-(4- iodophenyl)tropane; [\18\F]fluoropropylcarbomethoxy nortropane) 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. [\18\F]FP-CIT is currently a schedule II controlled substance because it can be derived from cocaine, a schedule II substance, via ecgonine, also a schedule II substance. 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 [\18\F]FP-CIT.

Nanosyn 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.

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.

Novitium Pharma 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.

Organic Consultants, LLC. DBA Cascade Chemistry, 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.

Mycrodose Therapeutics 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.

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 information.

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 its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.

AndersonBrecon, 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.