ISO 18977:2026

• Abstract:

  This document specifies the safety and quality requirements for herbal dispensing services. It is applicable to facilities related to large-scale herbal dispensaries, in-house hospital dispensaries and medium to large commercial dispensaries. It does not apply to dispensing services in medical clinics where herbal preparations are dispensed to patients by or under the supervision of the prescribing practitioners. The specifications regarding tools and equipment used in these services are excluded.

• Status: Published
• Publication Date: 10-Aug-2026
• ICS: 11.120.10 - Medicaments
• ICS: 11.120.99 - Other standards related to pharmaceutics
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 11-Aug-2026
• Due Date: 20-Mar-2026
• Completion Date: 11-Aug-2026

Overview

ISO 18977: Traditional Chinese Medicine - Requirements for Herbal Dispensing Services establishes safety and quality requirements for herbal medicine dispensing facilities. Developed by the International Organization for Standardization (ISO), this standard targets medium to large dispensaries, in-house hospital dispensaries, and commercial dispensing businesses engaged in the preparation and distribution of Traditional Chinese Medicine (TCM) herbal products. It details specifications for operational procedures, personnel, sanitation, documentation, and quality management-excluding requirements for tools, equipment, and clinics where herbal preparations are dispensed directly by prescribing practitioners.

ISO 18977 serves as an important guideline for organizations seeking to ensure the safe, consistent, and compliant dispensing of herbal medicines, in accordance with recognized international best practices.

Key Topics

ISO 18977 outlines a comprehensive framework to guarantee the quality and safety of herbal dispensing services. The standard covers the following core requirements:

• Facility & Environment:

  • Controlled dispensing rooms, medicinal herb storage, and workrooms with specified hygiene and environmental controls.
  • Regular monitoring of temperature, humidity, and sanitation.
  • Segregation of tasks and storage to minimize contamination risk.

• Personnel Management:

  • Clearly defined roles, including a dispensing supervisor with suitable training and expertise.
  • Health and hygiene screening for workers.
  • Ongoing training and evaluation of staff related to dispensing and hygiene procedures.

• Standard Operating Procedures (SOPs):

  • Written SOPs covering all aspects of herbal dispensing, equipment maintenance, sanitation, and material management.
  • Documentation of every step, from medicinal herb intake and storage, to handling expired products.

• Documentation & Traceability:

  • Robust documentation practices for each batch, ensuring traceability of herbal products, ingredients, and dispensing activities.
  • Maintenance and safe storage of dispensing records, electronic data, and revision management.

• Herbal Medicines & Materials:

  • Procedures for the receipt, inspection, and storage of medicinal herbs and materials.
  • Clear labeling and segregation of materials to prevent cross-contamination.
  • Regular quality checks and protocols for handling expired or substandard products.

Applications

ISO 18977 is relevant to a wide range of organizations and scenarios within the herbal medicine supply chain:

• Large-Scale Herbal Dispensaries: Ensures standardized practices for high-volume preparation and storage of herbal medicines, supporting both safety and efficiency.
• Hospital Dispensaries: Facilitates compliance with regulatory requirements for in-house preparation and handling of TCM herbal prescriptions.
• Commercial Herbal Dispensaries: Promotes consumer confidence through adherence to best practices and international standards for product quality and safety.
• Herbal Supply Chain Management: Supports traceability, quality assurance, and risk mitigation from raw material intake to finished product dispensing.

Implementing ISO 18977 can help enhance operational credibility, support regulatory alignment, improve product safety, and foster trust with patients and healthcare stakeholders.

Related Standards

To further support quality control and compliance in the field of Traditional Chinese Medicine, organizations may also reference:

• ISO 22217: Traditional Chinese Medicine - Storage requirements for raw materials and decoction pieces.
• ISO 21371: Traditional Chinese Medicine - Labelling requirements of products intended for oral or topical use.
• ISO 24512: Water - Guideline for the management of drinking water utilities and for the assessment of drinking water services.

Together, these standards provide a structured approach for ensuring high standards of safety, quality, and reliability in TCM herbal dispensing services across diverse healthcare and commercial settings.

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Keywords: ISO 18977, Traditional Chinese Medicine, herbal dispensing services, herbal medicine standard, quality requirements, safety, facility management, personnel, SOP, documentation, traceability, TCM, commercial dispensary, hospital dispensary, herbal supply chain.

International
Standard
ISO 18977
First edition
Traditional Chinese medicine —
2026-08
Requirements for herbal dispensing
services
Médecine traditionnelle chinoise — Exigences relatives aux
services de délivrance de plantes médicinales
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
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CH-1214 Vernier, Geneva
Phone: [phone]
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Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Facilities and environment . 2
4.1 Facility requirements .2
4.1.1 General .2
4.1.2 Dispensing room.2
4.1.3 Medicinal herbs storage cabinet.2
4.1.4 Workroom .3
4.2 Water .3
4.3 Environment .3
5 Personnel . 4
5.1 Composition of organization .4
5.2 Dispensing supervisor .4
6 Standard operating procedure (SOP) documents . 4
6.1 General .4
6.2 Dispensing SOP documents .4
6.2.1 General .4
6.2.2 SOP documents on dispensing procedures .4
6.2.3 SOP documents on equipment and device maintenance .5
6.2.4 SOP documents on medicinal herbs management.5
6.2.5 SOP documents on subsidiary material management .5
6.3 Sanitation SOP documents .5
7 Documentations . 6
7.1 Composition of documents .6
7.2 Maintenance of documents . . .6
8 Dispensing . 7
8.1 Dispensing procedures .7
8.2 Packaging procedures .7
9 Sanitation . 8
9.1 Workers .8
9.2 Workroom .8
10 Medicinal herbs, materials and finished herbal preparations . 9
10.1 Receipt of medicinal herbs and materials .9
10.2 Storage .9
10.3 Storage of medicinal herbs.9
10.4 Final inspection of finished herbal preparations .9
11 Alterations . 9
12 Training and evaluation of employees . 10
13 Self-inspection . 10
14 Traceability . 10
Annex A (informative) Requirements for dispensing special medicinal herbs .11
Bibliography .12

iii
Foreword
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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
International Standard ISO 18977:2026(en)
Traditional Chinese medicine — Requirements for herbal
dispensing services
1 Scope
This document specifies the safety and quality requirements for herbal dispensing services. It is applicable
to facilities related to large-scale herbal dispensaries, in-house hospital dispensaries and medium to large
commercial dispensaries.
It does not apply to dispensing services in medical clinics where herbal preparations are dispensed to
patients by or under the supervision of the prescribing practitioners. The specifications regarding tools and
equipment used in these services are excluded.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
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
herbal medicine dispensary
place where medicinal herbs (3.3) are either traditionally processed or prepared into decoctions or other
dosage forms, or both, in accordance with prescriptions or in-pharmacy formulation guidelines, and
subsequently dispensed
Note 1 to entry: This term does not include dispensing services provided within medical clinics where herbal
preparations are dispensed directly to patients by, or under the supervision of, the prescribing practitioners.
3.2
dispensing
process by which medicinal herbs (3.3) are traditionally prepared through cleaning, cutting, roasting,
steaming, or other processing techniques, and subsequently extracted, decocted, or formulated into specific
dosage forms according to an individualized prescription or standardized in-pharmacy formulation
3.3
medicinal herb
material collected from plants, minerals or animals, processed or to be processed for use as raw material for
finished herbal preparations (3.6)

3.4
subsidiary material
material used for packaging, storing and labelling of finished herbal preparations (3.6)
3.5
herbal preparation
dosage form made with medicinal herbs (3.3) to be used for the purposes of treatment or prevention of
a certain disease for a specific individual according to the prescription or guidelines for in-pharmacy
formulation
3.6
finished herbal preparation
dosage form that has been dispensed and is ready to be administered to patients
Note 1 to entry: This applies to traditionally processed herbal formulations that have been processed into decoction
or dosage forms ready for administration.
3.7
standard operating procedure
SOP
documented sets of instructions or guidelines that describe the steps and specifications for carrying out a
particular task or process
Note 1 to entry: SOPs aim to standardize operations, ensure consistency, and promote efficiency within organizations.
4 Facilities and environment
4.1 Facility requirements
4.1.1 General
The herbal medicine dispensary is equipped with the necessary and qualified equipment for preparation
and decoction, such as a dispensing room, medicinal herbs storage facility, and workroom. Regular records
and inspections shall be conducted to ensure proper operation and eliminate errors in the process.
General safety includes as following:
a) As part of the operational procedure, the ID code of critical equipment used for preparation should be
documented.
b) Equipment that are broken, malfunctioning, or otherwise unusable should be removed or marked as
unavailable.
c) Lubricating oil or refrigerant shall be managed to avoid affecting the quality of finished herbal
preparations.
4.1.2 Dispensing room
The dispensing room shall be furnished with a clean cabinet to store and preserve opened in-use medicinal
herbs and granules, table and also machine and devices to dispense herbal preparations. The dispensing
room should be maintained with well controlled sanitation. The weighing devices shall be provided after
verifying their accuracy.
4.1.3 Medicinal herbs storage cabinet
a) The storage cabinet for medicinal herbs , partially prepared and finished herbal preparations shall
operate under controlled temperature and humidity conditions as specified in ISO 22217.
b) The cabinet shall be well-ventilated and kept out of direct light.

c) The cabinet shall be protected against rodents, vermin and dust.
d) Standard names of medicinal herbs shall be written on the tabs. The labelling of medicinal herbs shall
be in accordance with ISO 21371.
e) The layout of medicinal herbs shall:
1) facilitate reducing labour intensity, convenient for adjusting and adding herbs;
2) help prevent mistakes and accidents;
3) aid in memory retention;
4) contribute to the management of herbal pieces;
5) support division of labour and cooperation among personnel.
4.1.4 Workroom
a) The arrangement of machinery and equipment in the workroom shall align with the relevant workflow.
b) Machinery and equipment crucial to quality, such as decoction machines or packaging machines, should
be distinctly identified with non-removable numbers or codes. Additionally, the prescription name,
internal preparation number, and date of use on critical machinery or equipment shall be documented.
c) Walls should be finished with decorative materials that are waterproof, moisture-resistant, and mould-
resistant, and that can withstand scrubbing, if a large amount of water is used.
d) Plumbing systems should be clearly labelled to indicate their content and flow direction for easy
differentiation.
e) The workroom drain should be designed to prevent reflux and regularly undergo disinfection.
f) If grinding of medicinal herbs into powders is performed, the workroom should be divided into
compartments to prevent dust accumulation and contamination.
g) The herbal extracts workroom should be equipped with steam emission facilities and washable
concentration units.
h) The workroom should provide facilities for tap water or other suitable water sources of appropriate
quality (refer to 4.2).
i) If feasible, a separate locker room and handwashing facility should be established, independent of the
workroom.
j) The workroom for preparing herbal powder or pills should be equipped with a magnetic device to
remove any foreign metallic objects.
4.2 Water
The water dispensing facilities should be according to ISO 24512. In situations where strict conformance
with these requirements is not possible due to regional limitations, sufficient effort should be made to
ensure that the dispensing facilities adhere to the best practices outlined in the standard.
4.3 Environment
Regular monitoring of temperature and humidity levels, suitable for the preparation and storage conditions,
should be conducted to ensure they are adequate. Periodic checks should be carried out to maintain the
appropriate environmental conditions in the designated areas.

5 Personnel
5.1 Composition of organization
An individual with a suitable education and expertise should be assigned to oversee the herbal medicine
dispensary, ensuring effective management and operation of the facility.
5.2 Dispensing supervisor
The dispensing supervisor is responsible for the management of the herbal medicine dispensary, overseeing
procedures, sanitation, storage, and the preparation of finished herbal preparations through compounding
decoction pieces. The dispensing supervisor shall adhere to the following guidelines:
a) To ensure proper dispensing, the supervisor shall document their name on the preparation/sanitation
standard document, grant permission for operation, and oversee the process.
b) It shall be verified whether the finished herbal preparations are prepared in accordance with
prescriptions or guidelines for in-pharmacy formulations. Additionally, any instances of adulteration or
substitution of medicinal herbs shall be thoroughly investigated and recorded.
c) The supervisor should be aware of local requirements when conducting inspect of sanitation and
storage practices.
d) The supervisor is responsible for maintaining appropriate storage condi
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