Perfecting the legal framework for specially controlled drugs

The Circular was issued to concretize the provisions of the amended Law on Pharmacy 2024 and Decree No. 163/2025/ND-CP, while establishing a unified legal basis for managing high-risk drugs and drug ingredients, such as addictive drugs, psychotropic drugs, drug precursors, radioactive drugs, and other substances under special control.

Accordingly, the Circular promulgates specific lists including: the list of addictive active ingredients; the list of psychotropic active ingredients; the list of drug precursors; and the table of concentration and content limits for addictive ingredients, psychotropic ingredients, and drug precursors in combination drugs. At the same time, the document specifies the list of drugs and active ingredients banned from use in certain sectors and fields as announced by the Ministry of Health.

The Circular also details regulations on storage, production, preparation, dispensing, usage, disposal, handover, transportation, reporting, and record-keeping for specially controlled drugs and drug ingredients at establishments operating pharmacy activities for non-commercial purposes. For the first time, numerous management processes have been standardized to align with the new provisions of the amended Law on Pharmacy and modern management systems, creating a foundation to strengthen oversight, enhance traceability, and prevent drug loss.

Standardizing management from hospitals to pharmacies

One of the core contents of the Circular is clearly defining the responsibilities of each stage in the management of specially controlled drugs. For medical facilities, addictive drugs, psychotropic drugs, precursor drugs, and drug ingredients that are addictive active ingredients, psychotropic active ingredients, or drug precursors must be stored in separate storehouses or dedicated cupboards equipped with secure locks, and must not be mixed with other medicines. In the absence of a separate warehouse or cupboard, a distinct area with clear signage must be arranged to avoid confusion. In treatment departments, these drug groups must be stored separately, with strict monitoring during handovers between shifts to minimize the risk of loss.

The dispensing and clinical use of addictive, psychotropic, and precursor drugs must follow a strict process. Treatment departments and clinics are required to create drug requisition forms, track import-export-inventory data, and return unused medicines in compliance with regulations. Qualification standards for drug managers at hospitals and non-commercial pharmaceutical establishments are also clearly stipulated. Depending on the specific type of drug, the manager must possess appropriate professional qualifications, holding at least an intermediate degree in pharmacy, or be officially assigned the duty in writing. Particularly for radioactive drugs, managers must undergo radiation safety training and satisfy relevant specialized requirements.

Regarding the retail system, pharmacies must maintain comprehensive logbooks to track imports, exports, and inventory, while storing prescriptions, drug return receipts, and customer information logs for all specially controlled substances. This is considered a crucial step to enhance traceability and control the distribution flow of addictive drugs, psychotropic drugs, and precursors on the market.

Promoting record digitization and enhancing traceability

A notable highlight of the Circular is that it allows establishments to utilize electronic records and logbooks instead of paper files, provided they fulfill requirements regarding security, data integrity, and storage capacity. Electronic data must ensure full information according to the regulated forms, be encrypted and protected during transmission and storage, and guarantee accuracy, confidentiality, and retrieval capability whenever necessary. Pharmaceutical businesses and non-commercial pharmaceutical facilities are permitted to store records and documents in either paper or electronic formats, but they must guarantee the ability to manage, look up, and recover data throughout the statutory retention period. Upon the expiration of the retention period, the facility must establish a council to carry out record destruction procedures.

Regarding the supply of radioactive drugs, medical examination and treatment facilities licensed to manufacture or prepare radioactive drugs may supply their self-produced or self-prepared medicines to other medical facilities when their production volume exceeds actual internal demand. Both supplying and receiving facilities must bear responsibility for the quality, safety, and efficacy of the drugs. Annually, the supplying facilities of radioactive drugs must fulfill reporting regimes as prescribed.

Furthermore, the Circular provides detailed regulations on the system of records and logbooks for manufacturing, import-export, wholesale, and retail establishments, as well as storage, testing, clinical trial facilities, and non-commercial pharmaceutical entities. These establishments must maintain and store complete logs of imports, exports, and inventory balances; delivery notes; purchase invoices; and related documentation for each group of specially controlled drugs.

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