6.3 Non-prescrition Drug

Segmentation of prescription drugs and non-prescription drugs

Apart from prescription drugs which are dispensed by the pharmacist and taken by the patient according to the prescription issued by a physician/dentist, drugs requiring guidance and non-prescription drugs exist which general public may purchase directly at pharmacies and drugstores and use at one’s own discretion.

As non-prescription drugs can be purchased/taken by the general consumer at his/her own discretion, sellers are required to provide information to the buyer, and they are divided into Class 1, Class 2 and Class 3 based on risk level, each category with a defined degree of necessity of providing information.

  • Class 1 Drugs : Drugs for which pharmacists are required to provide information and only under a pharmacist’s management and guidance can be sold/handed over
  • Class 2 Drugs :Drugs which can only be sold and handed over at stores where pharmacists/registered sellers are working full time, and providing information has to be done on best effort basis.
  • Class 3 Drugs :Drugs whose risk level is the lowest. Unless the buyer directly requests for it, they can be sold without any legal obligation to provide explanation in particular.

Drugs requiring guidance are, distinct from non-prescription drugs, categorized as “quasi-prescription drugs”, and Switch OTC Drugs, which have just been switched from prescription to non-prescription drug and thus haven’t been certified risks as non-description drug, as well as Direct OTC Non-prescription Drugs, which have never been used as prescription drugs, fall into that category.