Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

The Drug Enforcement Administration is proposing to adjust the established 2015 aggregate production quota for difenoxin, diphenoxylate (for conversion), and marijuana which are schedule I and II controlled substances under the Controlled Substances Act.

Three synthetic cannabinoids: N-(1-amino-3-methyl-1-oxobutan- 2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N- (1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-car boxamide (AB-PINACA), and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- yl)methanone (THJ-2201) were temporarily placed in schedule I of the Controlled Substances Act by a final order published by the Drug Enforcement Administration on January 30, 2015 (80 FR 5042). This means that any person that wishes to manufacture AB-CHMINACA, AB-PINACA, or THJ-2201 after January 30, 2015, must be registered with the Drug Enforcement Administration and have obtained a manufacturing quota pursuant to 21 CFR part 1303. The Drug Enforcement Administration cannot issue individual manufacturing quotas for AB-CHMINACA, AB-PINACA, or THJ-2201 until it establishes aggregate production quotas. Therefore, this notice proposes the 2015 aggregate production quotas for AB-CHMINACA, AB- PINACA, and THJ-2201.

United States Pharmacopeial Convention applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants United States Pharmacopeial Convention registration as an importer of those controlled substances.

Cerilliant Corporation applied to be registered as an importer of basic classes of controlled substances. The DEA grants Cerilliant Corporation registration as an importer of the controlled substances.

The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule three synthetic cannabinoids (SCs) into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act (CSA). The substances are: (1) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H- indazole-3-carboxamide (``AB-CHMINACA''); (2) N-(1-amino-3-methyl-1- oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (``AB-PINACA''); and (3) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanon e (``THJ-2201''). This action is based on a finding by the Administrator that the placement of these synthetic cannabinoids and their optical, positional, and geometric isomers, salts, and salts of isomers into schedule I of the CSA 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, import, export, engage in research, or possess), or propose to handle these SCs.

Research Triangle Institute applied to be registered as an importer of a certain basic class of narcotic controlled substance. The DEA grants Research Triangle Institute registration as an importer of this controlled substance.

Cody Laboratories, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The DEA grants Cody Laboratories, Inc. registration as an importer of those controlled substances.

Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Euticals, Inc. registration as a manufacturer of those controlled substances.

Lin Zhi International, Inc., applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Lin Zhi International, Inc. registration as a manufacturer of those controlled substances.