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

The Drug Enforcement Agency is correcting a rule that published November 14, 2022, in the Federal Register, to clarify the effective date is 30 days from the date the rule published.

With the issuance of this final rule, the Drug Enforcement Administration removes [\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. Prior to the effective date of this rule, [\18\F]FP-CIT was 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 removes 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, engage in research, import, export, conduct instructional activities or chemical analysis with, or possess) or propose to handle [\18\F]FP-CIT.

Vici Health Sciences, 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 amending its regulations by adding and revising provisions which enable DEA to hold registrants or applicants in default when they fail to timely request a hearing, or otherwise fail to participate in hearings. DEA is also amending its regulations to include an answer provision which will regulate how registrants respond to an Order to Show Cause (OTSC). These changes involve the revocation, suspension, or denial of a registration and do not affect other types of hearings.

The Drug Enforcement Administration (DEA) is establishing a specific listing and DEA Chemical Control Number for tert-butyl 4- (phenylamino)piperidine-1-carboxylate (also known as 1-boc-4-AP; and CAS Number: 125541-22-2) and its salts as a list I chemical under the Controlled Substances Act. Although 1-boc-4-AP is not specifically listed as a list I chemical of the Controlled Substances Act with its own unique Chemical Control Number, it has been regulated as a list I chemical in the United States since May 15, 2020, as a carbamate of N- phenylpiperidin-4-amine, a list I chemical. Therefore, DEA is simply amending the list I chemicals list in its regulations to include a separate listing for 1-boc-4-AP, a currently controlled list I chemical.

Organix Chemistry Solutions 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.