Drug Enforcement Administration 2014 – Federal Register Recent Federal Regulation Documents

Ten synthetic cathinones: 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP); alpha- pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2- (methylamino)butan-1-one (butylone); 2-(methylamino)-1-phenylpentan-1- one (pentedrone); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone (4-FMC); 3-fluoro-N- methylcathinone (3-FMC); naphthylpyrovalerone (naphyrone); and alpha- pyrrolidinobutiophenone ([alpha]-PBP) were temporarily placed in schedule I of the Controlled Substances Act (CSA) by a final order published by the Drug Enforcement Administration (DEA) on March 7, 2014 (79 FR 12938). This means that any manufacturer that wishes to manufacture 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP after March 7, 2014, must be registered with the DEA and have obtained a manufacturing quota for 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4- FMC, 3-FMC, naphyrone, or [alpha]-PBP pursuant to 21 CFR part 1303. The DEA cannot issue individual manufacturing quotas for 4-MEC, 4- MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP unless and until it establishes an aggregate production quota. Therefore, this notice proposes a 2014 aggregate production quota for 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP.

Four synthetic cannabinoids: quinolin-8-yl 1-pentyl-1H-indole- 3-carboxylate (PB-22; QUPIC); quinolin-8-yl 1-(5-fluoropentyl)-1H- indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22); N-(1-amino-3-methyl-1- oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB- FUBINACA); and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- indazole-3-carboxamide (ADB-PINACA) were temporarily placed in schedule I of the Controlled Substances Act (CSA) by a final order published by the DEA on February 10, 2014 (79 FR 7577). This means that any manufacturer that wishes to manufacture PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA after February 10, 2014, must be registered with the DEA and have obtained a manufacturing quota for PB-22, 5F-PB-22, AB- FUBINACA, or ADB-PINACA pursuant to 21 CFR part 1303. The DEA cannot issue individual manufacturing quotas for PB-22, 5F- PB-22, AB-FUBINACA, or ADB-PINACA unless and until it establishes an aggregate production quota. Therefore, this notice proposes a 2014 aggregate production quota for PB-22, 5F-PB-22, AB-FUBINACA, and ADB- PINACA.

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance 5[alpha]- pregnan-3[alpha]-ol-11,20-dione (alfaxalone), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, or possess) or propose to handle alfaxalone and substances containing alfaxalone.

The Drug Enforcement Administration (DEA) proposes to place the substance suvorexant ([(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7- methyl-1,4-diazepan-1-yl][5-methyl-2-(2H-1,2,3-triazol-2- yl)phenyl]methanone), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act (CSA). This proposed scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess), or propose to handle suvorexant.