Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

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.

Mylan Technologies, 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.

Nanoysn 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 (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.

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.

Organic Standards Solutions International, 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.

The Drug Enforcement Administration (DEA) proposes to establish the 2023 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

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.

Groff NA Hemplex 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.

Curia Missouri, 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.

Eli-ElSohly Laboratories, 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.

Chattem Chemicals, 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.

Curia Wisconsin, 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.

This final rule adopts without change an interim final rule with request for comments published in the Federal Register on April 7, 2022, placing daridorexant ([(S)-2-(5-chloro-4-methyl-1H- benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-( 2H-1,2,3- triazol-2-yl)phenyl)methanone), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of such isomers is possible, in schedule IV of the Controlled Substances Act (CSA). With the issuance of this final rule, the Drug Enforcement Administration maintains daridorexant in schedule IV of the CSA.

The Drug Enforcement Administration is proposing the control of 4-piperidone, its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, whenever the existence of such is possible, as a list I chemical under the Controlled Substances Act. The Drug Enforcement Administration finds that 4-piperidone is used in the illicit manufacture of the controlled substance fentanyl, and is important to the manufacture of the controlled substance fentanyl because it cannot be replaced by other chemicals in its respective synthetic pathways which are used in the illicit manufacture of fentanyl. If finalized, this action would subject handlers of 4-piperidone to the chemical regulatory provisions of the Controlled Substances Act and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of 4-piperidone. As such, all transactions of chemical mixtures containing 4-piperidone will be regulated at any concentration and will be subject to control under the Controlled Substances Act.