The Ministry of Health has just issued Circular 18/2026/TT-BYT to strengthen the management of drugs and drug ingredients subject to special control such as addictive drugs, psychotropic drugs, precursors used as drugs and radioactive drugs. The Circular will take effect from July 16, 2026.
Stricter management of special drugs
The new Circular is built on the revised Pharmaceutical Law of 2024 and Decree 163/2025/ND-CP. This document clearly stipulates the list of drugs and pharmaceutical substances subject to special control, and at the same time provides detailed guidance on the production, preservation, transportation, distribution, use and destruction of these drugs.
The goal is to limit losses, prevent misuse and increase drug traceability.
Hospitals and pharmacies must comply with strict regulations
At medical facilities, addictive drugs, psychotropic drugs and precursor drugs must be stored in separate warehouses or cabinets with safety locks. If there is no separate area, the facility must arrange a separate storage place with clear signs.
The issuance and use of these types of drugs must be closely monitored through drug receipts, import-export-inventory monitoring books and the process of returning unused drugs.
Those in charge of specially controlled drug management must also meet professional requirements. Specifically for radioactive drugs, managers must be trained in radiation safety.
Retail pharmacies must keep complete purchase records, prescriptions and related information to serve inspection and supervision when necessary.
An important new point of the Circular is to allow the use of electronic records and books instead of paper records if security and data storage requirements are met.
Electronic data must be safely protected, ensure accuracy and be accessible when needed. This helps reduce administrative procedures, save time and improve management efficiency.
In addition, pharmaceutical establishments are allowed to store records in paper or electronic form but must ensure the ability to look up and recover data throughout the storage period as prescribed.
New regulations on radioactive drugs
The Circular also allows medical facilities capable of producing or mixing radioactive drugs to supply excess drugs to other medical facilities. Supplying and receiving units must be responsible for the quality, safety and effectiveness of drugs.
Every year, these facilities must implement a reporting regime according to the regulations of the Ministry of Health.
