Drug Enforcement Administration 2021 – Federal Register Recent Federal Regulation Documents

The Drug Enforcement Administration proposes placing the substance amineptine (chemical name: 7-[(10,11-dihydro-5H- dibenzo[a,d]cyclohepten-5-yl)amino]heptanoic acid), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 United Nations Convention on Psychotropic Substances. If finalized, this action would 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 with, or possess), or propose to handle, amineptine.

The Drug Enforcement Administration (DEA) is issuing this direct final rule to amend DEA regulations to clarify that either the purchaser or the supplier may enter a supplier's DEA registration number on the Single-Sheet DEA Form 222.

The Administrator of the Drug Enforcement Administration is issuing this order to extend the temporary schedule I status of six synthetic cathinones, as identified in this order. The schedule I status of these six substances currently is in effect until July 18, 2021. This temporary order extends the temporary scheduling of these six substances for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first.

Aspen API, 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.

AMRI Rensselaer, 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.

The Drug Enforcement Administration (DEA) is publishing this final rule to revise existing regulations for narcotic treatment programs (NTPs) to allow the operation of a mobile component associated with a DEA-registered NTP to be considered a coincident activity permitted under the NTP's registration. Based on these revisions, NTP registrants that operate or wish to operate mobile components (in the State in which the registrant is registered) to dispense narcotic drugs in schedules II-V at remote location(s) for the purpose of maintenance or detoxification treatment do not need a separate registration for such mobile component. This final rule waives the requirement of a separate registration at each principal place of business or professional practice where controlled substances are dispensed for those NTPs with mobile components that fully comply with the requirements of this rule. These revisions to the regulations are intended to make maintenance or detoxification treatments more widely available, while ensuring that safeguards are in place to reduce the likelihood of diversion.

Cambrex Charles City 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.

Purisys, LLC. 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.

Andersonbrecon Inc. DBA PCI of Illinois 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.

Xcelience 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.

Usona Institute 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 places 1-(1,3-benzodioxol- 5-yl)-2-(ethylamino)pentan-1-one (known as N-ethylpentylone or ephylone) and its optical, positional, and geometric isomers, salts, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action makes permanent the current imposition of 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 N-ethylpentylone.

Cambrex Charles City 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.

Fisher Clinical Services, 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.

This final rule adopts, with a change as mentioned below, an interim final rule with request for comments published in the Federal Register on October 30, 2020, placing oliceridine, N-[(3- methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6- oxaspiro[4.5]decan-9-yl]ethyl{time} )amine fumarate, 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, in schedule II of the Controlled Substances Act. In response to an error in the chemical name of oliceridine as noted by one of the commenters to the interim final rule, the Drug Enforcement Administration makes a correction to the above mentioned chemical name of oliceridine by removing the word ``fumarate'' to read as N-[(3- methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6- oxaspiro[4.5]decan-9-yl]ethyl{time} amine. This change clarifies the control of oliceridine free base and its salts, to include the fumarate salt, by definition.

This final rule adopts, without change, an interim final rule with request for comments published in the Federal Register on October 6, 2020, placing the substance remimazolam, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the Controlled Substances Act. With the issuance of this final rule, DEA maintains remimazolam, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the Controlled Substances Act.

Almac Clinical Services Incorp. (ACSI) 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.

SpecGX, 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.

Lipomed 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.

Experic 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.

Patheon API Manufacturing, 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.