Drug Enforcement Administration December 2022 – Federal Register Recent Federal Regulation Documents

With the issuance of this final rule, the Drug Enforcement Administration removes fenfluramine (chemical name: N-ethyl-[alpha]- methyl-3-(trifluoromethyl)phenethylamine), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts is possible, from the schedules of the Controlled Substances Act. Prior to the effective date of this rule, fenfluramine was a schedule IV controlled substance. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule IV controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, engage in research, import, export, conduct instructional activities or chemical analysis with, or possess) or propose to handle fenfluramine.

The Drug Enforcement Administration (DEA) published a document in the Federal Register on August 9, 2022, concerning an application for an Importer of Controlled Substances. The document contained an incorrect drug schedule for coca leaves.

Scottsdale Research Institute 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.

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.

This final order establishes the initial 2023 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.