1. Reasons for Amendment

This amendment aims to improve the efficiency of manufacturing over-the-counter drugs and reporting items by adding the efficacy/effectiveness of compounding ingredients among the standards for manufacturing drugs and reinforce the safety management of drugs by reflecting safety information on drugs containing benzalkonium chloride and drugs containing methyl salicylate according to domestic and international safety information and the results of the Central Pharmaceutical Affairs Advisory Committee.

2. Major Provisions

A. Add the efficacy/effectiveness of selenium to Chapter 1 Products of Vitamins, Minerals, etc., based on the expected effectiveness and minimum quantity of selenium, and the status of domestic and foreign product approval, etc. (Chapter 1 of Attached Table 1) 

B. Adjust the precautions for use according to the drug safety information

 1) Set forth precautions for inhalation in the precautions for use of drugs containing benzalkonium chloride (spray for rhinitis, medicine for external hemorrhoids, medicine for athlete's foot/tinea) (Chapters 10 through 12 of Attached Table 1)

 2) Set forth salicylic acid poisoning and reproductive developmental toxicity in the precautions for the use of drugs containing methyl salicylate (athlete's foot/tinea medicine, external pain reliever, external antiseptic) (Chapters 12 through 14 of Attached Table 1)