Japan proposes law on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

In order to clarify the regulation under the Pharmaceutical Affairs Law, the Minister of Health, Labour and Welfare of Japan proposes to designate the following substances as “Shitei Yakubutsu” (designated substances). Manufacture, import, sale, simple ownership and the use of “designated substances” are banned except for the “proper uses” (see below). The proposed substances as “Shitei Yakubutsu” are:

1. N-(4-Chlorophenyl)-2-methyl-N-(1-phenethylpiperidin-4-yl)propanamide (4Cl-iBF,p-CIBF)

2. 1-(3,5-Dimethoxy-4-propoxyphenyl)propan-2-amine (3C-P) 

3. N-(1-Phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide (THF-F)

4. N-(4-Fluorophenyl)-2-methyl-N-(1-phenethylpiperidin-4-yl)propanamide (4-FIBF,p-FIBF)

5. N-(2-Methoxybenzyl)-N-methyl-1-(4-methylphenyl)propan-2-amine (4-MMA-NBOMe)