The Ministry of Health has officially promulgated Circular No. 18/2026/TT-BYT, detailing select articles of the Law on Pharmacy and Decree No. 163/2025/ND-CP concerning controlled drugs and medicinal raw materials. The updated regulatory framework focuses on synchronizing asset registries, standardizing the complete operational chain from manufacturing to storage, enhancing traceability metrics, and driving digital transformation across high-risk pharmaceutical categories.
The validated legal schedules, institutional standardization parameters, and data digitization mechanisms feature:
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Integration of Legal Registries and Operational Protocols:
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The Circular establishes synchronized master registries including: the schedule of narcotic drug substances; the schedule of psychotropic drug substances; the schedule of drug precursors; maximum concentration and content limits for these substances within combined drug formats; and the registry of banned substances across designated sectors.
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The statutory text defines strict protocols tracking the storage, manufacturing, compounding, dispensing, clinical utilization, disposal, handover, transportation, reporting, and record-keeping of these controlled categories across non-commercial pharmaceutical entities.
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Physical Storage Rules and Personnel Classifications at Healthcare Facilities:
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Physical Storage Constraints: Healthcare establishments are legally required to isolate narcotics, psychotropics, precursors, and related raw materials within dedicated locked warehouses or distinct secure cabinets separate from conventional products. If separate infrastructure is unavailable, a clearly signed, dedicated section must be engineered to mitigate error risks. Clinical wards must isolate these inventories and enforce strict shifts-handover logs to eliminate loss risks.
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Dispensing Workflows: Clinical deployment requires formal drug requisitions, verified stock balance tracking, and the systematic return of unused quantities in compliance with regulatory formats.
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Managerial Staffing Benchmarks: Managers oversight positions require an intermediate pharmacy degree or higher, or a formal written mandate. For radiopharmaceuticals, supervising personnel must maintain certified training in radiation safety alongside a written corporate assignment.
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Retail Network Enforcement and Radiopharmaceutical Allocation Mechanics:
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Retail pharmacies are mandated to maintain comprehensive digital or physical logs tracking balance charts, prescription history files, returned drug minutes, and patient identity profiles linked to any controlled item sales.
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Regarding radiopharmaceuticals, licensed healthcare facilities authorized to manufacture or compound these materials are permitted to supply surplus inventory exceeding their internal clinical demand to alternative medical institutions. Both the supplying and receiving entities retain legal liability for quality, safety, and therapeutic efficacy, subject to a mandatory annual reporting cycle.
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Digital Transformation Integration and Enforcement Timeline:
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Circular 18 officially permits institutions to migrate from physical paper ledgers to electronic record systems, provided the software architectures satisfy national criteria for data security, encryption protocols, and transactional integrity during transit and storage. Upon the expiration of the statutory retention timelines designated for each drug class, facilities must establish an internal committee to oversee the formal destruction of records.
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This master administrative circular is scheduled to take full legal effect on July 16, 2026.
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