The high-dose Vitamin B6 ‘Pyridoxine Hydrochloride 300mg’ is likely to be classified as a prescription drug.

Although pyridoxine doses up to 250mg are classified as a health functional food abroad, experts reached a consensus that the 300mg dose of the same drug should be classified as a prescription drug in consideration of the side effects that arise from the long-term use of the higher dose, and similar cases where a low-dose formulation of an approved drug had been classified as an OTC and the high-dose formulation as an ETC.

The Ministry of Food and Drug Safety disclosed the minutes of the meeting held by the drug classification subcommittee of the pharmaceutical policy committee