Japan's health ministry has put out for comment the detailed rules behind a ban on pharmacies selling prescription drugs without a prescription. The ban comes from the Pharmaceuticals and Medical Devices Act as amended by Law No. 37 of 2025. The drafts spell out who is covered, when a pharmacist may make an exception, and what must be written down afterwards.
The rule and its exception
Under Article 36-3(2) of the amended Act, a pharmacy operator may not sell or hand over designated drugs to anyone who has not received a prescription from a doctor, dentist or veterinarian, unless there is a justifiable reason. The Act has the health minister designate which drugs fall under the ban.
The draft notification does that by exclusion. It covers the drugs the Act classes as pharmacy drugs (Article 4(9)(2)), minus those defined in Article 2(17)(3). The overview does not say which products that last carve-out holds.
A separate draft ministry ordinance sets the terms for the exception. A pharmacist may sell only if the buyer meets all three of the following conditions:
- The buyer is already using the drug on a doctor's or dentist's prescription.
- The buyer is in a temporary situation where obtaining the drug by prescription is difficult because of special circumstances, such as being unable to receive medical care.
- It is hard to steer the buyer to a pharmacy-manufactured medicine, a guidance-required medicine or an over-the-counter product instead.
What the pharmacist must check and record
When a buyer has no prescription, the pharmacy operator must have the pharmacist confirm whether a justifiable reason exists. In making the call the pharmacist checks that the buyer is the person who will use the drug, and looks at how the buyer and the user have bought the same drug from other pharmacies. The pharmacist also confirms that anyone who received information and guidance on the drug understood it and has no questions.
Sales under the exception are limited to the quantity needed for those circumstances. After making such a sale, the pharmacy operator must record the reasons and keep the record for two years. A companion change would let operators keep and create those records electronically rather than on paper.
Other items in the package
The same ordinance draft also changes which manufacturing-process categories are excluded from a quality-control conformity survey. Under the amended Act, categories that need particular care are subject to a survey by the Pharmaceuticals and Medical Devices Agency. The draft adds two exclusions: categories where a specified conformity survey was carried out on site and found compliant, and categories to which the manufacturing process of a drug belongs where that drug passed certain on-site surveys or confirmations with a compliant result.
It further adds several written instructions and reports, covering registered handover stores and specified dispensing outsourcing, to the duties that can be handled electronically.
Timing
The ministry opened comment on 16 October 2026 and will take submissions until 23:59 on 14 November 2026. Comments must be in Japanese, include reasons and the sender's contact details, and will not receive individual replies. Some may be published.
Both drafts are scheduled for promulgation in late November 2026. They take effect when the provisions in Supplementary Article 1(3) of the amending law come into force, except that part of the ordinance's miscellaneous tidying-up provisions takes effect on promulgation. The drafts give no calendar date for the main commencement.