Drug Enforcement Administration July 2017 – Federal Register Recent Federal Regulation Documents

Importer of Controlled Substances Application: R & D Systems, Inc.
Document Number: 2017-16064
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Isosciences, LLC
Document Number: 2017-16060
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Sigma-Aldrich International GMBH
Document Number: 2017-16059
Type: Notice
Date: 2017-07-31
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: United States Pharmacopeial Convention
Document Number: 2017-15693
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2017-15692
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances.
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Document Number: 2017-15691
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Organic Consultants, Inc.
Document Number: 2017-15690
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2017-15689
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2017-15688
Type: Notice
Date: 2017-07-26
Agency: Drug Enforcement Administration, Department of Justice
Mohammed S. Aljanaby, M.D.; Decision and Order
Document Number: 2017-15494
Type: Notice
Date: 2017-07-25
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I
Document Number: 2017-14880
Type: Rule
Date: 2017-07-14
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryl fentanyl or acryloylfentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into Schedule I. This action is based on a finding by the Administrator that the placement of acryl fentanyl into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances will be imposed 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, acryl fentanyl.
Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical
Document Number: 2017-14878
Type: Rule
Date: 2017-07-14
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is finalizing the designation of the chemical alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, as a list I chemical under the Controlled Substances Act (CSA). The DEA proposed control of APAAN, due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine. This rulemaking finalizes, without change, the control of APAAN as a list I chemical. This action does not establish a threshold for domestic and international transactions of APAAN. As such, all transactions involving APAAN, regardless of size, shall be regulated. In addition, chemical mixtures containing APAAN are not exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of APAAN shall be regulated pursuant to the CSA. However, manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption.
Sassan Bassiri, D.D.S.; Decision and Order
Document Number: 2017-14597
Type: Notice
Date: 2017-07-12
Agency: Drug Enforcement Administration, Department of Justice
Schedules of Controlled Substances: Removal of Naldemedine From Control
Document Number: 2017-14482
Type: Proposed Rule
Date: 2017-07-12
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes to remove naldemedine (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,7,9-trihydroxy- N-(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7 a- hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-6-carbo xamide) including its salts from the schedules of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Naldemedine is currently a schedule II controlled substance because it can be derived from opium alkaloids. 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 naldemedine.
Phong Tran, M.D.; Decision and Order
Document Number: 2017-14070
Type: Notice
Date: 2017-07-05
Agency: Drug Enforcement Administration, Department of Justice