Over-the-counter drugs (OTC drugs) are drugs that are sold at pharmacies and drugstores and can be purchased under the advice of a pharmacist or registered seller without a prescription from a doctor or dentist.
Based on the Supreme Court ruling on online sales of over-the-counter drugs, the Pharmaceutical Affairs Law was partially revised in order to ensure safety in the use of drugs and drugs. As a result of this revision, a new category of pharmaceuticals requiring guidance was newly established , and regulations concerning the sales of pharmaceuticals, etc. were reviewed.
-
1 Classification of drugs that can be purchased at pharmacies and drug stores
Click here for the classification of drugs that can be purchased at pharmacies and drug stores
-
2 Pharmaceutical sales method
Click here for information on how to sell pharmaceuticals
-
3 How to display medicines
Click here for information on how to display pharmaceutical products
-
4 Online sales of over-the-counter drugs
Click here for online sales of over-the-counter drugs
1 Classification of drugs that can be purchased at pharmacies and drug stores
〇Guidance- required drugs : Drugs that have a particularly high risk of side effects and require face-to-face information provision and guidance from a pharmacist
Includes ingredients that require pharmacists to provide face-to-face information and guidance, such as those that have been designated as Class 1 OTC drugs for a short period of time (items immediately after switching) and powerful drugs. thing.
Example: New drugs for hay fever and rhinitis (reference) Click here for a list of medicines requiring guidance 
*Over-the-counter drugs are still categorized into three risk categories.
〇Category 1 drugs : Drugs with high risk of side effects, etc.
Items that require special attention because they may cause health damage that interferes with daily life.
Examples: stomach medicines (H2 blockers), some hair medicines, etc.
〇Category 2 drugs : Drugs with a moderate risk of side effects, etc.
Items that contain ingredients that may cause health hazards that interfere with daily life.
Examples: Major cold medicines, antipyretic analgesics, etc.
〇 Class 3 drugs : Drugs with relatively low risk of side effects, etc.
Containing ingredients that may cause physical disorders or disorders, although not to the extent that they interfere with daily life.
Examples: major intestinal remedies, digestive medicines, poultices, etc.
Classification of drugs (comparison table before and after revision)
2 About pharmaceutical sales methods
〇 About sales of designated class 2 drugs
Designated second-class drugs are drugs that require special attention among the second-class drugs. It was decided to take measures (posts such as pop-up displays, verbal communication) to appropriately convey the content to the staff.
〇 Sales, etc. of pharmaceuticals that may be abused, etc.
Drugs with a risk of abuse will be sold after confirming the following items (1) to (3).
(1) If the purchaser is a young person such as a junior or senior high school student, the name and age (2) Status of purchases of medicines at other stores (3) Attempting to purchase more than the amount deemed necessary (in principle, one per person) the reason if
〇 Records related to sales, etc.
When selling guidance-required pharmaceuticals or class 1 pharmaceuticals, distributors are obliged to describe the necessary information in writing and keep records. As a result, the purchaser may be asked to sign that he or she understands the content of the information provided.
| Pharmaceuticals requiring guidance | Over-the-counter drugs | |||
|---|---|---|---|---|
| Category 1 | Category 2 | Class 3 | ||
|
Seller (information provider) |
pharmacist No specific sales*1 |
pharmacist Specific sale possible |
Pharmacist or registered seller*2 Specific sale possible |
|
|
Providing information proactively without asking questions |
Provide information face-to-face using documents (obligation) |
Provide information using documents (obligation)
|
Strive to provide information (obligation to make efforts) |
If necessary |
|
Provision of information, etc. in case of consultation |
obligation | obligation | ||
|
Confirmation that the purchaser is the user |
If necessary | |||
|
Sale after confirmation of buyer's understanding |
obligation | If necessary | ||
*1: The sale of over-the-counter drugs via the Internet, telephone, catalogs, etc. is called specific sales.
*2: A registered salesperson is a specialist who has passed a prefectural examination to confirm qualifications related to drug sales and has been registered.
You can sell and consult about Class 2 and Class 3 drugs.
3 How to display medicines
The display on the outer box of the drug and how to place it in the store are differentiated according to the classification of drugs requiring guidance and over-the-counter drugs (1st to 3rd), so that the purchaser can also understand the difference in risk. In addition, guidance-required drugs and class 1 drugs are displayed as an over-the-counter*.
* A display method in which the seller hands over the drug to the purchaser over the counter.
4 Online sales of over-the-counter drugs
Under appropriate rules, all over-the-counter drugs are now available for Internet sales (referred to as specific sales under the Pharmaceutical Affairs Law) .
The flow of Internet sales is as follows.
(1) Confirmation of the user's condition, etc. → (2) Individual provision of information, etc. according to the user's condition, etc. → (3) Notification of understanding of the provided information, etc. → (4) Shipment of goods
* A list of stores that sell online can be found on the website of the Ministry of Health, Labor and Welfare (a list of over-the-counter drug sales sites). will be published in In order to safely purchase medicines online, make sure that the store is listed.
