ISO/TS 24943:2026

Traditional Chinese medicine — Requirements for decoction pieces prescription

This document specifies the general requirements, content and writing requirements for the prescription of decoction pieces. It notably regulates the qualification of prescription writing, the prescription of precious medicines, the prescription of toxic and anaesthetic medicines, and institution-based prescriptions. This document applies to prescription writing, dispensing and storage.

Médecine traditionnelle chinoise — Exigences relatives à la prescription de pièces de décoction

General Information

• Status: Published
• Publication Date: 11-May-2026
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 2 - Quality and safety of manufactured TCM products
• Current Stage: 6060 - International Standard published
• Start Date: 12-May-2026
• Due Date: 29-Jan-2028
• Completion Date: 12-May-2026

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

• 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.

• 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.

• 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.

• 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.

• 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:

• 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.

• 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.

• 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.

• Regulatory and Health Authorities

  • Assists with the harmonization of prescription standards across institutions and jurisdictions, strengthening oversight and regulatory compliance.

• 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.

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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.

Standards Content (Sample)

Technical
Specification
ISO/TS 24943
First edition
Traditional Chinese medicine —
2026-05
Requirements for decoction pieces
prescription
Médecine traditionnelle chinoise — Exigences relatives à la
prescription de pièces de décoction
Reference number
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 Acquisition of the right to prescription .2
4.2 Drawing up of prescription .2
4.3 Printing of the prescription .2
4.4 Timeliness of the prescription . .2
4.5 Revision of the prescription .2
4.6 Preservation and destruction of the prescription .2
5 Content and writing requirements for the prescription of decoction pieces . 2
5.1 Contents of the prescription of decoction pieces .2
5.1.1 Precription contents .2
5.1.2 Prescription preface .2
5.1.3 Prescription text .3
5.1.4 Prescription postscript.3
5.2 Prescription of decoction pieces writing requirements .3
5.3 Prescription writing requirements for finished Chinese medicinal product .3
5.4 Written format of the prescription of Chinese medicines .4
6 Management of prescription rights for decoction pieces and qualification for
dispensation and delivery . 4
6.1 Modification of the prescription .4
6.2 Herbal dispensary personnel .4
7 Requirements for the prescription of narcotic drugs and toxic drugs . 4
Annex A (informative) Prescription patterns and writing examples of Chinese medicines in
TCM clinics . . 5
Annex B (informative) Requirements for narcotic or toxic Chinese medicines prescription in
China . 7
Bibliography . 14

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
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related to conformity assessment, as well as information about ISO's adherence to the World Trade
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
The prescription requirements of Chinese medicines are a crucial component of the service process of
Chinese medicines. This encompasses the whole process, starting from the doctor's medical treatment
guided by the traditional Chinese medicine (TCM) theory of syndrome differentiation and treatment, leading
to the writing of the patient prescription. Unfortunately, this aspect has not received adequate attention,
significantly affecting the quality of medical care and services, as well as the safety and effectiveness of TCM
medication, and the vital rights of consumers.
Therefore, it is vital to standardize and establish a traceable medication service process for Chinese
medicines. This will promote effective communication among doctors, pharmacists and patients, improving
relationships between doctors and patients, enhancing levels of medical service, reducing medical errors
and accidents, ensuring the safety and effectiveness of people's medication, safeguarding the legitimate
rights and interests of consumers, and making contributions to human health.
Prescribing is an important medical activity that requires serious and rigorous behavior. It is also the first
and most critical step in the entire service process.
[1] [2] [3]
This document is consistent with the provisions of ISO 18668-2 , ISO 18668-4 , ISO 20333 , ISO 20334
[4]
and other relevant International Standards.

v
Technical Specification ISO/TS 24943:2026(en)
Traditional Chinese medicine — Requirements for decoction
pieces prescription
1 Scope
This document specifies the general requirements, content and writing requirements for the prescription of
decoction pieces. It notably regulates the qualification of prescription writing, the prescription of precious
medicines, the prescription of toxic and anaesthetic medicines, and institution-based prescriptions.
This document applies to prescription writing, dispensing and storage.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
prescription of decoction pieces
medical document issued by a licenced doctor for the diagnosis and treatment of patients
Note 1 to entry: The prescription of decoction pieces includes details such as the names, quantities, preparation
methods and other specifications of traditional Chinese medicinal herbs and formulations. It is subject to review,
dispensation and verification by a prescription-reviewing pharmacist (see Note 4 to entry), and it also serves as a
voucher for the distribution of medicinal products.
Note 2 to entry: The prescription of decoction pieces is a written notice from doctors to traditional Chinese medicine
dispensing personnel (see Note 5 to entry) that represents both the basis of traditional Chinese medicine dispensing,
and the voucher of valuation and statistics, which has legal, technical and economic significance.
Note 3 to entry: The prescription of decoction pieces provides a written record and evidence of doctors’ syndrome
differentiation and treatment, reflecting the doctors' syndrome differentiation and drug use requirements.
Note 4 to entry: The "prescription-reviewing pharmacist" refers to a professional in the herbal pharmacy responsible
for reviewing doctors' prescriptions.
Note 5 to entry: "Traditional Chinese medicine dispensing personnel" refers to a professional in the dispensing room
responsible for the preparation, dispensing and management of prescriptions.

4 General requirements
4.1 Acquisition of the right to prescription
Individuals in possession of the relevant educational background and knowledge, who have obtained
medical qualification(s) according to the local health and pharmaceutical industries, and who are employed
by medical institutions, are granted prescription rights by that medical institution.
NOTE Employees of medical institutions can include freelance doctors, self-employed persons and owners of
medical institutions.
4.2 Drawing up of prescription
A doctor of traditional Chinese medicine should prescribe based on the principle of syndrome differentiation
and treatment, specific medical needs, prevention, health care, standard of diagnosis and treatment, drug
indication, pharmacological action, usage, dosage, contraindication, adverse reaction and precautions, etc.
4.3 Printing of the prescription
Appropriate warning labels should be marked on prescriptions of narcotic and toxic drugs to ensure proper
handling and awareness of their special status and usage guidelines.
4.4 Timeliness of the prescription
Requirements for the timeliness of prescriptions should be specified based on the local situation.
4.5 Revision of the prescription
The prescription should be legibly written and should not be altered; if amendment is necessary, the
prescriber shall sign and date the amended section to indicate the revision.
4.6 Preservation and destruction of the prescription
Medical institutions responsible for dispensing prescriptions are required to maintain them properly.
NOTE The retention period for different types of prescriptions can be dependent on guidelines set by the medical
and health administrative authorities of the respective country or region.
5 Content and writing requirements for the prescription of decoction pieces
5.1 Contents of the prescription of decoction pieces
5.1.1 Precription contents
The preface, text and postscript of the prescription contain standardized content, specified in the following
subclauses, and shall adhere to the requirements of safety, efficiency and cost-effectiveness.
5.1.2 Prescription preface
The prescription preface shall include:
a) the name of the medical treatment, prevention or health care institution;
b) the prescription number;
c) the patient’s name, sex and age;
d) the patient's inpatient record number, department or ward and bed number;

e) the patient's clinical diagnosis/TCM diagnosis, including the disease name and syndrome type (do not
write if the disease name is not clear);
f) the date of prescribing.
5.1.3 Prescription text
The prescription text shall be marked with a distinctive heading or symbol to label the prescription, such as
"Rp" or "R" (the abbreviation of Latin "recipe"). Decoction pieces shall include their name, dosage and usage.
5.1.4 Prescription postscript
The prescription postscript shall encompass the doctor's signature or authorized stamp, or both. Items with
special requirements can be added depending on the actual situation, such as price, drug amount or the
special signature of the pharmaceutical professional and technical personnel for reviewing, dispensing,
checking and distributing drugs.
5.2 Prescription of decoction pieces writing requirements
5.2.1 The name of the decoction pieces should be written in the official local language.
5.2.2 The dosage should be expressed in statutory unit of measurement, using Arabic numerals. The
principle should be in "gram" (g) as a unit, i.e. with "g" (unit name) following the numerical value.
5.2.3 The number of decoction pieces should be used as a "dose".
The quantity of doses should be specified directly, followed by the prescription’s usage and dosage
instruction. This includes daily dosage, dosage forms (decocting, wine-soaking, powder-baking, pill-making,
capsules-filling, etc.), dosage frequency, medication methods (oral and external use, etc.) and administration
requirements (administered warm, administered cool, administered at draught, slow administration,
administered before meal, administered after meal, administered on empty stomach, etc.).
EXAMPLE One dose per day, decocting it with 400ml water, administered warm, in the morning and evening.
5.2.4 Regarding the use of decoction pieces under the administration of toxic drugs and anaesthetics,
local laws and regulations can apply.
5.2.5 Regarding prohibited or restricted use of certain decoction pieces, regulations of the local medical
and health management departments of the country or region can apply.
5.3 Prescription writing requirements for finished Chinese medicinal product
5.3.1 According to the TCM diagnosis (including disease name and syndrome type), syndrome
differentiation or a combination of syndrome differentiation and disease differentiation is used to select a
suitable finished Chinese medicinal product.
5.3.2 The name of the decoction pieces in the hospital should be approved by the drug supervision and
administration department.
5.3.3 Usage and dosage should be used according to the conventional usage and dosage prescribed in the
drug instructions. If the patient has a special condition and needs to exceed the dosage, the reasons should
be noted and signed again.
5.3.4 Tablets, pills, capsules and granules are taken as tablets, pellets, granules and bags. Ointments
and cream are taken as the unit in branches and boxes. Solution preparations and injections are in units of
branches and bottles, and the dosage should be marked.

5.3.5 Medicine with strong or toxic components should not be reused. Finished medicinal products with
the same function or with the same toxicity decoction pieces should not be superimposed.
5.3.6 Chinese Medicines injection should be prescribed separately.
5.3.7 The format of the prescription can be consistent with the electronic medical record.
5.4 Written format of the prescription of Chinese medicines
For the written format of decoction pieces and finished Chinese medicinal product prescription, local
authority requirements can apply. See Annex A for written examples of decoction pieces and finished
Chinese medicinal product prescription.
6 Management of prescription rights for decoction pieces and qualification for
dispensation and delivery
6.1 Modification of the prescription
Each item on a prescription written by the doctor shall remain unaltered. If changes are required, a single
line should be drawn through the revised content, ensuring that the original text remains legible. The doctor
should re-sign their name and include the date of modification.
Only the prescribing doctor is authorized to amend a written prescription. If there is a lack of certain
medicines or prescription errors, the doctor shall retract and revise the presicription, with a signature
confirming the change.
6.2 Herbal dispensary personnel
Herbal dispensary personnel have the right to supervise and review herbal prescriptions, and to participate
in the process of reasonable use of herbs. In cases involving herbal prescriptions with contraindications,
such as those involving "Eighteen Incompatibilities,
...