Overview
ISO/TS 24943:2026, titled Traditional Chinese medicine - Requirements for decoction pieces prescription, is an international technical specification developed by the International Organization for Standardization (ISO). This document sets forth the general requirements, content, and writing standards for prescriptions involving traditional Chinese medicine (TCM) decoction pieces. The standard covers prescription writing, dispensing, storage, the management of precious, toxic, and anaesthetic medicines, as well as institution-based prescription practices. By establishing a consistent framework, ISO/TS 24943:2026 aims to ensure the safety, effectiveness, and traceability of TCM prescription practices globally.
Key Topics
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Prescribing Rights and Qualifications
- Only healthcare professionals with appropriate qualifications and authorization from medical institutions are permitted to write TCM decoction piece prescriptions.
- The document regulates the process for the acquisition and management of prescription rights, emphasizing compliance with local health industry requirements.
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Prescription Content and Writing Standards
- Prescriptions are required to include specific sections: preface (institution name, patient information, diagnosis), text (prescription details including drug names, dosage, and usage), and postscript (signature and any additional required information).
- Dosages must be expressed in statutory units, typically grams, and written in the official local language.
- Special procedures are outlined for toxic and anaesthetic drugs, as well as for precious or restricted medicines.
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Dispensing and Storage
- Institutions must ensure proper management, preservation, and destruction of prescriptions according to local regulations. The standard addresses procedures for prescription modification and the scope of authority for both prescribers and dispensary personnel.
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Management of Narcotic, Toxic, and Precious Medicines
- Detailed guidance is provided for appropriately labeling, managing, and registering prescriptions involving narcotic and toxic medicines.
- The qualifications for handling, reviewing, and dispensing such medicines are clarified, with reference to national or regional requirements.
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Institutional Application
- The standard applies to various medical institutions, from TCM clinics to larger healthcare centers, promoting standardized and safe medication practices.
Applications
ISO/TS 24943:2026 delivers practical value for several sectors involved in the prescription and administration of Chinese herbal medicines:
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Traditional Chinese Medicine Clinics
- Ensures consistency and quality in prescription writing and dispensing, minimizing medical errors.
- Supports safe handling of precious, toxic, or regulated substances.
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Hospitals and Healthcare Institutions
- Facilitates training and qualification management for staff handling TCM prescriptions.
- Supports effective storage, preservation, and traceability of medical documents related to TCM decoction pieces.
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Pharmacy and Dispensary Operations
- Provides clear protocols for the review, revision, and dispensing of TCM prescriptions, and outlines best practices for managing at-risk substances.
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Regulatory and Health Authorities
- Assists with the harmonization of prescription standards across institutions and jurisdictions, strengthening oversight and regulatory compliance.
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Educational and Research Organizations
- Offers a reference for curricula development or research focusing on the safe and effective use of TCM decoction pieces.
Related Standards
ISO/TS 24943:2026 references several associated standards relevant to the field of TCM and prescription management:
- ISO 18668-2: Coding system for Chinese medicines - Part 2: Codes for decoction pieces.
- ISO 18668-4: Coding system for Chinese medicines - Part 4: Codes for Chinese herbal pieces.
- ISO 20333: Traditional Chinese medicine - Coding system of Chinese medicines.
- ISO 20334: Traditional Chinese medicine - Coding system of prescription and formulae.
Institutions adopting ISO/TS 24943:2026 are encouraged to consult these related documents to ensure comprehensive compliance and benefit from synergies in coding, safety, and operational practices within traditional Chinese medicine.
Keywords: ISO/TS 24943:2026, traditional Chinese medicine, decoction pieces prescription, TCM prescription requirements, herbal medicine standards, prescription management, toxic medicines, precious medicine, narcotic drugs regulation, TCM clinics compliance.