Good Supply Practice for Pharmaceutical Products

Order of the Ministry of Health of the Peoples Republic of China No. 90

The Good Supply Practice for Pharmaceutical Products, as deliberated and adopted at
the executive meeting of the Ministry of Health on November 6, 2012, is hereby issued and
shall come into force on June 1, 2013.
Minister: Chen Zhu
January 22, 2013
Good Supply Practice for Pharmaceutical Products
Chapter I General Provisions
Article 1 This Practice is formulated in accordance with the Drug Administration Law of the
Peoples Republic of China, and the Regulation for the Implementation of the Drug
Administration Law of the People's Republic of China for purposes of strengthening the
quality management of drug distribution, standardizing drug distribution behaviors and
guaranteeing the safety and effectiveness of drugs for humans.
Article 2 This Practice is a set of basic rules for drug distribution management and quality
control, and enterprises shall take effective quality control measures in drug purchase,
storage, sales, transportation and other links so as to guarantee the quality of drugs.
Article 3 Drug distributors shall strictly implement this Practice.
The sales of drugs by drug manufacturers and other activities concerning the storage and
transportation of drugs during the circulation process of drugs shall also conform to the
relevant requirements of this Practice.
Article 4 Drug distributors shall uphold honesty and trustworthiness and operate according
to law. False and fraudulent acts are prohibited.
Chapter II Quality Management for Wholesale of Pharmaceutical Products
Section I

Quality Management System

Article 5 Enterprises shall establish quality management system, determine quality policy,
formulate quality management system document, carry out quality planning, quality control,

quality assurance, quality improvement, and quality risk management and other activities in
accordance with the requirements of relevant laws and regulations and this Practice.
Article 6 The quality policy document formulated by enterprises shall make clear the
overall quality objective and requirements of the enterprises and shall be implemented
throughout the whole course of operation activities related to drugs.
Article 7 The quality management system of enterprises shall suit the scope of business
and scale, including organization, personnel, facilities and equipment, quality management
system document, appropriate computer system, etc.
Article 8 Enterprises shall organize and conduct internal audit periodically and at the time
when significant change takes place in the key elements of the quality management system.
Article 9 Enterprises shall conduct analysis on the internal audit, formulate appropriate
measures for improving quality management system according to the analysis conclusions,
continuously improve quality control level, and ensure the sustainable and effective
operation of the quality management system.
Article 10 Enterprises shall conduct assessment, control, communication, and audit on the
quality risks in the course of drug circulation by way of forecasting or retrospection.
Article 11 Enterprises shall evaluate the quality management system of drug suppliers
and purchase units and verify their quality assurance capability and quality credibility; if
necessary, conduct on-the-spot investigation.
Article 12 Enterprises shall allow all of their members to participate in quality
management. The personnel of all departments and posts shall correctly understand and
perform their duties and assume appropriate quality responsibility.
Section II Organizing Institution and Quality Management Responsibility
Article 13 Enterprises shall establish the organization or post that suits their operating
activities and quality management and explicitly define the responsibilities, authorities and
interrelationships.
Article 14 Enterprises responsible person is the primary responsible person of drug
quality, who is comprehensively responsible for the daily management of the enterprise and
for providing necessary conditions, ensuring that the quality management department and
quality management personnel effectively perform their duties, and ensuring that the
enterprise achieves its quality objective and distributes drugs according to the requirements

of this Practice.
Article 15 The post of person responsible for quality in the enterprise shall be held by
senior management personnel, who shall be comprehensively responsible for drug quality
management, independently perform duties and have jurisdiction over drug quality
management within the enterprise.
Article 16 Enterprises shall establish quality management department to effectively carry
out quality management. The responsibilities of the quality management department shall
not be performed by other departments and personnel.
Article 17 Quality management department shall perform the following responsibilities:
(I) Urge the personnel of relevant departments and posts to execute the laws and
regulations for drug management and this Practice;
(II) Organize the formulation of quality management system document and guide and
supervise the execution of the document;
(III) Audit the legality of supplier and purchase unit, the legality of the drug purchased and
the legal qualification of the sales personnel of supplier and the purchase personnel of
purchase unit, and conduct dynamic management on the changes of the contents audited;
(IV) Collect and manage quality information and establish drug quality archive;
(V) Perform drug acceptance, guide and supervise the quality management in the links of
drug purchase, storage, maintenance, sales, rejection, transportation, etc.;
(VI) Confirm nonconforming drugs and implement supervision on the handling process of
nonconforming drugs;
(VII) Investigate, handle and report drug quality complaints and quality accidents;
(VIII) Report counterfeits and low-quality drugs;
(IX) Handle drug quality inquiry;
(X) Guide the setting of quality control functions of computer system;
(XI) Examine the operating authority of computer system and the establishment and
updating of basic data of quality management;
(XII) Organize the validation and calibration of relevant facilities and equipment;
(XIII) Manage drug recall;
(XIV) Report adverse reactions to drugs;
(XV) Organize the internal audit and risk assessment of quality management system;
(XVI) Organize the investigation and evaluation on the quality management system and
service quality of drug supplier and purchase unit;
(XVII) Organize the examination on the transportation conditions and quality guarantee
capability of the carrier authorized for transportation;
(XVIII) Assist in quality management education and training; and

(XIX) Other responsibilities to be performed by quality management department.

Section III Personnel and Training
Article 18 The personnel of enterprise engaging in drug operation and quality
management shall comply with the requirements of relevant laws and regulations and this
Practice on qualification and shall not conduct any practice prohibited by relevant laws and
regulations.
Article 19 Enterprises responsible person shall have an educational degree of junior
college and above or the professional technical title above the middle level, received basic
training on professional knowledge on the pharmaceutical field, and be familiar with the laws
and regulations on drug management and this Practice.
Article 20 Enterprises person responsible for quality shall have an educational degree
above regular college, qualification of licensed pharmacist, and work experience of more
than 3 years in drug operation and quality management, and have the capability to make
correct judgment and guarantee implementation in quality management.
Article 21 The responsible person of enterprise quality management department shall
have the qualification of licensed pharmacist and work experience of more than 3 years in
drug operation and quality management and be capable of independently solving the quality
problems in operation process.
Article 22 Enterprise shall allocate quality management, acceptance and maintenance
personnel meeting the following qualification requirements:
(I) The personnel engaging in quality management shall have the educational background of
pharmaceutical technical secondary school or college and above of specialized university or
the professional technical title above primary level in pharmacy;
(II) The personnel engaging in acceptance and maintenance shall have the educational
background above professional technical secondary school in pharmacy or medicine, biology,
chemistry, etc. or the professional technical title above the primary level in pharmacy;
(III) The personnel engaging in the acceptance of traditional Chinese medicinal materials
and Chinese herbal medicine shall have the educational background above the professional
technical secondary school in science of Chinese pharmacology or the professional technical
title above intermediate level in science of Chinese pharmacology; the personnel engaging in
the maintenance of traditional Chinese medicinal materials and Chinese herbal medicine
shall have the educational background above the professional technical secondary school in
science of Chinese pharmacology or the professional technical title above primary level in
science of Chinese pharmacology; and the acceptance personnel directly purchasing

traditional Chinese medicinal materials from producing areas shall have the professional
technical title above the intermediate level in science of Chinese pharmacology.
The enterprise dealing with vaccines shall allocate two and more professional technical
personnel who are especially responsible for vaccine quality management and acceptance.
The professional technical personnel shall have bachelor's degree or higher in preventive
medicine, pharmacy, microbiology or medicine and the professional technical title above the
intermediate level, and have work experience of more than 3 years in vaccine management
or technical work.
Article 23 The personnel engaging in quality management and acceptance shall be on job
and on duty and shall not hold other jobs concurrently.
Article 24 The personnel engaging in purchase shall have the educational background
above professional secondary technical school in pharmacy or medicine, biology, chemistry,
etc. The personnel engaging in sales and storage shall have the educational background
above senior high school.
Article 25 Enterprises shall provide pre-job training and continued training relating to the
responsibilities and work contents for the personnel on each post so as to meet the
requirements of the practice.
Article 26 Training contents shall include relevant laws and regulations, drug professional
knowledge and skills, quality management system, responsibilities, operation procedures for
post, etc.
Article 27 Enterprises shall formulate annual training plan and conduct training according
to training management system and enable relevant personnel to correctly understand and
perform their duties.
Article 28 The personnel engaging in the storage and transportation of drugs under
special control and refrigerated and frozen drugs shall receive the training on relevant laws
and regulations and professional skills and shall not take up post until passing examination.
Article 29 Enterprises shall formulate the personal hygiene management system for
employees. The clothing of the personnel on posts dealing with storage, transportation, etc.
shall meet the requirements on personal protection and product protection.
Article 30 The personnel on posts directly contacting drugs such as those of quality
management, acceptance, maintenance, and storage shall receive pre-job and annual health
examination and establish health records. The personnel suffering from infectious diseases

or other diseases that can possibly contaminate drugs shall not engage in jobs in which they
could directly contact drugs. The personnel with physical conditions not meeting the specific
requirements of a certain post shall not take up the post.
Section IV Quality Management System Document
Article 31 The quality management system document formulated by enterprises shall
comply with the actual situation of enterprises. The document includes quality management
system, departmental and post responsibilities, operating procedures, files, reports, records,
vouchers, etc.
Article 32 The drafting, revision, audit, approval, distribution, and custody, modification,
revocation, substitution, destruction of documents shall be conducted according to the
operating procedures for document management and the relevant records shall be kept.
Article 33 Documents shall indicate the title, category, purpose, and document number
and version number. The text shall be accurate, distinct, and understandable.
Documents shall be stored by category for the convenience of review.
Article 34 Enterprises shall periodically examine and revise documents. The documents
used shall be the ones that are currently in effect. Abolished or invalid documents shall not
appear on job site unless they are for future reference.
Article 35 Enterprises shall ensure that all posts obtain necessary documents
corresponding to their work contents and strictly carry out their work according to
provisions.
Article 36 Quality management system shall include the following contents:
(I) Provisions on the internal audit of quality management system;
(II) Provisions on quality veto;
(III) Management of quality management documents;
(IV) Quality information management;
(V) Provisions on qualification of supplier, purchase unit, sales personnel of supplier,
purchase personnel of purchase unit, etc.;
(VI) Management of drug purchase, receiving, acceptance, storage, maintenance, sales,
delivery from storage, and transportation;
(VII) Provisions on the drug under special control;
(VIII) Management on validity of drug;
(IX) Management of nonconforming drug and drug destruction;
(X) Management of drug rejection;

(XI) Management of drug recall;

(XII) Management of quality inquiry;
(XIII) Management of quality accidents and quality complaints;
(XIV) Provisions on reports about adverse reactions to drugs;
(XV) Provisions on environmental health and personal health;
(XVI) Provisions on quality education, training and assessment;
(XVII) Management of the custody and maintenance of facilities and equipment;
(XVIII) Management on validation and calibration of facilities and equipment;
(XIX) Management of records and vouchers;
(XX) Management of computer system;
(XXI) Provisions on execution of drug electronic supervision;
(XXII) Other contents to be specified.
Article 37 The responsibilities of departments and posts shall include:
(I) Responsibilities of quality management, purchase, storage, sales, transportation, finance,
information management, and other departments;
(II) Job responsibilities of enterprises responsible person, person responsible for quality and
quality management, purchase, storage, sales, transportation, finance, information
management, and other departmental responsible persons;
(III) Job responsibilities of quality management, purchase, receiving, acceptance,
maintenance, sales, outbound check, transportation, finance, information management,
etc.;
(IV) Other job responsibilities relating to drugs-related operations.
Article 38 Enterprises shall formulate the operating procedures for such links as drug
purchase, receiving, acceptance, storage, maintenance, sales, outbound check,
transportation, and computer system;
Article 39 Enterprises shall establish the records relating to drug purchase, acceptance,
maintenance, sales, outbound check, after-sales return and withdrawal after purchasing,
transportation, storage and transportation temperature and humidity monitoring, treatment
of nonconforming drugs, etc., and ensure that they are authentic, complete, accurate,
effective, and traceable.
Article 40 When data are recorded through computer system, relevant personnel shall not
enter or check data before logging in through authorization and password according to
operating procedures; data modification shall be examined by quality management
department and conducted under its supervision. The record of modification course shall be
kept.

Article 41 Written records and vouchers shall be timely filled in and shall be legible, and
shall not be altered at random and shall not be torn up. In case of modifying record, indicate
reasons, date and signature, and keep the original information clear and identifiable.
Article 42 Records and vouchers shall be kept for at least 5 years. The records and
vouchers of vaccines and drugs under special control shall be kept according to relevant
provisions.
Section V Facilities and Equipment
Article 43 Enterprises shall have operation sites and warehouses that suit the operation
range and scale of the drugs.
Article 44 The site selection, design, layout, construction, reconstruction, and
maintenance of warehouse shall meet the requirements on drug storage and prevent
contamination of drugs, cross-contamination of drugs, confusions, and errors.
Article 45 Drug storage operation area and auxiliary operation area shall be separated
from office area and living area by a certain distance and isolation measures shall be taken.
Article 46 The scale and conditions of warehouse shall satisfy the reasonable and safe
storage of drugs and meet the following requirements, and facilitate storage operation:
(I) The inside and outside of warehouse shall be clean, without contamination sources. The
ground in the warehouse area shall be hardened or greened;
(II) The internal wall and ceiling of warehouse shall be smooth and clean. The ground shall
be leveled. The structure of doors and windows shall be tight;
(III) Warehouse shall be provided with reliable safety and protection measures, and
controllable management on the access of irrelevant personnel for protecting the drugs from
theft, replacement or mixing with fake drugs shall be implemented; and
(IV) Protection measures against the impact of abnormal weather during outdoor loading
and unloading, handling, receiving, forwarding, and other operations shall be taken.
Article 47 The following facilities and equipment shall be provided for warehouse:
(I) Equipment for effective isolation between drugs and ground;
(II) Equipment for light-proofing, ventilation, moisture-proofing, insect-proofing, rodentproofing, etc.;
(III) Equipment for effectively regulating temperature and humidity and the indoor and
outdoor air exchange;
(IV) Equipment for automatic monitoring and recording of warehouse temperature and
humidity;

(V) Lighting equipment meeting the requirements on storage operation;

(VI) Operation area and equipment used for picking scattered goods, LCL shipment
operation and check;
(VII) Place for storing packaging materials;
(VIII) Special place for acceptance, shipment, and return of goods;
(IX) Special storage place for nonconforming drugs; and
(X) Storage facilities conforming to the national provisions for operation related to the drugs
under special control.
Article 48 Enterprises dealing with traditional Chinese medicinal materials and Chinese
herbal medicine shall have dedicated warehouse and maintenance operation site.
Enterprises directly purchasing the traditional Chinese medicinal materials from producing
areas shall arrange traditional Chinese medicine sample room (cabinet).
Article 49 Enterprises dealing with refrigerated and frozen drugs shall have the following
facilities and equipment:
(I) Cold storage that matches the operation scale and variety; in case of dealing with
vaccine, two and more independent cold storages shall be available;
(II) Equipment used for the automatic monitoring, display, recording, regulation, and alarm
of cold storage temperature;
(III) Standby generating set or double-circuit power supply system for the refrigerating
equipment of cold storage;
(IV) Facilities and equipment meeting the requirements on storage shall be provided for
drugs with special requirements on low temperature; and
(V) Refrigerator truck and vehicle-mounted freezer or heat-insulated container, and other
equipment.
Article 50 The transportation of drugs shall use closed cargo transportation means.
Article 51 The refrigerator truck, vehicle-mounted freezer, and heat-insulated container
for transportation of refrigerated and frozen drugs shall meet the requirements on the
temperature control during the transportation of drugs. Refrigerator truck shall have the
functions of automatic temperature regulation, temperature display, storage, and reading
temperature monitoring data; refrigerator container and heat-insulated container shall have
the functions of external display and collection of the temperature data in the container.
Article 52 The periodic examination, cleaning and maintenance of storage and
transportation facilities and equipment shall be managed by dedicated person and records
and archives shall be established.

Section VI Calibration and Validation

Article 53 Enterprises shall conduct calibration or verification for measuring instruments,
temperature and humidity monitoring equipment, etc. at regular intervals according to the
relevant provisions of the state.
Enterprises shall conduct pre-use validation, periodical validation, and validation when the
downtime exceeds the specified time on the facilities and equipment including cold storage,
storage and transportation temperature and humidity monitoring system, refrigerated
transportation, etc.
Article 54 Enterprises shall generate validation control document according to relevant
validation management system, including validation plan, report, evaluation, deviation
treatment, preventive measures, etc.
Article 55 Validation shall be conducted according to the predetermined and approved
plan. Validation report shall be audited and approved. Validation document shall be kept on
file.
Article 56 Enterprises shall correctly and rationally use relevant facilities and equipment
according to the parameters and conditions determined in validation.
Section VII Computer System
Article 57 Enterprises shall establish the computer system meeting the requirements on the
whole-course management of operation and quality control, achieve the traceability of drug
quality, and meet the conditions for implementing electronic supervision of drugs.
Article 58 The computer system of enterprise shall meet the following requirements:
(I) Server and terminal support the normal operation of the system;
(II) Safe and stable network environment, fixed mode for accessing the Internet, and safe
and reliable information platform;
(III) LAN for information transmission and data sharing between departments and posts;
(IV) Functions of generating, printing and managing the bills of drugs-related operations;
and
(V) Application software and relevant database meeting the requirements of the practice and
the actual needs of enterprise for management.
Article 59 The operations such as input, modification, saving, etc. of various data shall
meet the requirements on the range of authorization, operation procedures, and
management system and ensure the originality, authenticity, accuracy, security, and

traceability of the data.

Article 60 The data concerning enterprises operation and management in the operation of
the computer system shall be saved in secure and reliable way and backed up daily. Backup
data shall be stored in secure place. The storage time of recorded data shall meet the
requirements in Article 42 of the Practice.
Section VIII Procurement
Article 61 The purchase activities of enterprises shall meet the following requirements:
(I) Determine the legal qualification of supplier;
(II) Determine the validity of the drugs purchased;
(III) Verify the legal qualification of the sales personnel of supplier; and
(IV) Sign quality assurance agreement with supplier.
For the first commercial enterprise and first commercial varieties involved in purchase,
purchase department shall fill in relevant application form, which shall be examined and
approved by quality management department and the person responsible for enterprise
quality. If necessary, on-the-spot investigation shall be organized. The quality management
system of supplier shall be evaluated.
Article 62 For the examination of first commercial enterprise, the following materials
affixed with the original official seal shall be checked to verify the authenticity and validity:
(I) Copies of Pharmaceutical Production License or Pharmaceutical Operation License;
(II) Copies of business license or annual inspection certificate;
(III) Copies of authentication certificates of Good Manufacturing Practice for Pharmaceutical
Products or Good Supply Practice for Pharmaceutical Products;
(IV) Patterns of relevant seals and accompanying bills (certificates);
(V) Account name, bank of deposit and account number; and
(VI) Copies of Tax Registration Certificate and Organization Code Certificate.
Article 63 The validity of drugs shall be examined for purchasing first commercial
varieties. The copies of evidential documents for drug manufacturing or import approval
affixed with the original official seal of supplier shall be requested and examined. Such drugs
shall not be purchased until the documents are examined and found to be errorless.
The above materials shall be included in drug quality archive.
Article 64 Enterprises shall verify and keep the following materials of the sales personnel
of supplier:
(I) Copies of ID cards of sales personnel affixed with the original seal of supplier;

(II) Letter of authorization affixed with the original seal of the supplier and the seal of legal
representative or signatures; letter of authorization shall specify the name of authorized
person, ID number, and variety, region, and time limit of sales authorized;
(III) Materials relating to supplier and varieties supplied.
Article 65 The quality assurance agreement signed by and between enterprises and
supplier shall at least include the following contents:
(I) Clearly define the quality responsibilities of both parties;
(II) Supplier shall provide the materials complying with provisions and be responsible for the
authenticity and validity of the materials;
(III) Supplier shall issue invoices according to the provisions of the state;
(IV) The quality of drug shall comply with the relevant requirements of drug standard;
(V) The packaging, labeling, and instructions of drugs shall meet relevant provisions;
(VI) Quality assurance and responsibility of drug transportation;
(VII) Term of validity of quality assurance agreement.
Article 66 When drugs are purchased, enterprises shall ask for invoices from supplier. The
invoices shall list out the generic name, specification, unit, quantity, unit price, amount, etc.
of the drugs; if these items cannot be fully listed out, the List of Goods sold and Taxable
Services Provided shall be attached and affixed with the original special seal for invoice of
supplier and tax receipt number shall be indicated.
Article 67 The names of buyer and seller, amount, and name of product on the invoice
shall be consistent with the flow direction and amount of payment and name of product, and
shall correspond to the contents of financial account. Invoices shall be kept according to
relevant provisions.
Article 68 Purchase record shall be established for the drugs purchased. Purchase record
shall include the generic name of drug, dosage form, specification, manufacturer, supplier,
quantity, price, purchasing date, and other contents. In case of purchasing traditional
Chinese medicinal materials and Chinese herbal medicine, the producing area shall be
indicated.
Article 69 In special cases such as occurrence of a disaster, breakout of an epidemic,
emergency or clinical emergency treatment, etc. and other circumstances conforming to the
relevant provisions of the state, enterprises may purchase and sell drugs by way of direct
transfer. The drugs purchased shall not be put into the storage of the enterprise but directly
delivered to purchaser from supplier. Special purchase record shall be established to ensure
effective quality tracking and traceability.

Article 70 The drugs under special control shall be purchased strictly according to the
relevant provisions of the state.
Article 71 Enterprises shall conduct comprehensive quality evaluation on the overall
situation of drug purchase periodically, establish the quality record of drug quality evaluation
and supplier, and conduct dynamic tracking management.
Section IX Receiving and Acceptance
Article 72 Enterprises shall receive and accept the drugs arriving batch by batch according
to specified procedures and requirements and prevent nonconforming drugs from putting
into storage.
Article 73 When drugs arrive, receivers shall verify whether the transportation way meets
the requirements and check the drugs against the accompanying bills (documents) and
purchase record and ensure the consistency among bills, account, and goods.
Accompanying bills (documents) shall include supplier, manufacturer, generic name of drug,
dosage form, specification, batch number, quantity, receiving unit, receiving address, date
of delivery, and other contents and shall be attached with the original special seal for drug
delivery of supplier.
Article 74 When refrigerated and frozen drugs arrive, focused inspection shall be
conducted on the transportation mode and the temperature record during transportation,
transportation time, and other quality control situations and records shall be made. The
drugs with the temperature not meeting requirements shall be rejected.
Article 75 Receiver shall store the drugs complying with the receiving requirements in
quarantine area according to the requirements of the characteristics of variety or set status
flag, and notify of the acceptance. Refrigerated and frozen drugs shall be quarantined in cold
storage.
Article 76 The acceptance of drugs shall check the inspection report on the same batch
number of drugs according to the batch number of drugs. If the supplier is a wholesale
enterprise, the inspection report shall be affixed with the original special seal for quality
management. The inspection report shall be transmitted and stored as electronic data, but
the legality and validity shall be guaranteed.
Article 77 Enterprises shall conduct batch-to-batch sampling acceptance for the drugs
arriving each time according to acceptance provisions. The samples drawn shall be
representative.

(I) At least one package shall be inspected for the same batch number of drugs, but none of
the packages need to be opened if the manufacturing enterprise has special requirements on
quality control or if opening the package may affect the quality of drugs;
(II) In case of packaging abnormity and scattered goods and LCL such as damage, pollution,
seepage, seal damage, etc., open-case inspection shall be conducted for the minimum
number of packages;
(III) Open-case inspection need not be conducted for the crude drugs with complete
external package and seal and the biological products under lot release management.
Article 78 Acceptance personnel shall check and verify the appearance, packaging, label,
instructions, and relevant evidential document of the drug sampled; At the end of
acceptance, the intact sample sampled shall be placed back into the original packing box,
sealed and marked.
Article 79 The drugs under special control shall be accepted in special storage or special
zone according to relevant provisions.
Article 80 Acceptance record shall be kept for the drugs accepted, including the generic
name of drug, dosage form, specification, approval document number, batch number, date
of production, valid period, manufacturer, supplier, quantity of arrival, date of arrival,
number of acceptance, acceptance result, and other contents. Acceptance personnel shall
sign their names and acceptance date on acceptance record.
The acceptance record of traditional Chinese medicinal materials shall include the name of
product, producing area, supplier, quantity of arrival, quantity of acceptance, and other
contents. The acceptance record of Chinese herbal medicine shall include name of product,
specification, batch number, producing area, date of production, manufacturer, supplier,
quantity of arrival, and acceptance number. The acceptance record of Chinese herbal
medicine under approval document number management shall record approval document
number.
For nonconforming drugs in acceptance, the nonconforming items and treatment measures
shall be specified.
Article 81 For the drugs under electronic supervision, enterprises shall scan the electronic
supervision code of drug according to provisions and timely upload the data to Chinese drug
electronic supervision network system platform.
Article 82 Enterprises shall refuse to accept the drugs that are not printed or labeled with
Chinese drug electronic supervision code according to provisions or the printing of

supervision code does not comply with the specified requirements. In case that the
information of supervision code is inconsistent with the packaging information of the drug,
the supplier shall be inquired in a timely manner. The drugs shall not be put into storage
without confirmation; if necessary, report to local drug administration department.
Article 83 Enterprises shall establish inventory record. The drugs accepted as qualified
shall be timely warehoused and registered; the drugs accepted as unqualified shall not be
warehoused but treated by quality management department.
Article 84 In case of direct transfer of drugs according to the provisions in Article 69 of
the practice, enterprises may authorize purchasing unit to conduct drug acceptance.
Purchasing unit shall accept drugs and scan drug electronic supervision code and upload the
data strictly according to the requirements of the Practice and establish the special
acceptance record of direct transfer of drug. On the same day of acceptance, the relevant
information of acceptance record shall be transmitted to direct transfer enterprise.
Section X Storage and Maintenance
Article 85 Enterprises shall rationally store drugs according to the quality characteristics of
drugs and comply with the following requirements:
(I) Store drugs according to the temperature requirements indicated on packaging; if
specific temperature is not indicated on package, drugs shall be stored according to the
storage requirements specified in the Pharmacopoeia of the Peoples Republic of China;
(II) The relative humidity for storage of drug is 35%~75%;
(III) In case of storing drugs in manual operation storeroom, color code management shall
be implemented according to quality condition: Conforming drugs shall be green;
nonconforming drugs shall be in red; the drugs to be determined shall be in yellow;
(IV) Such measures as shielding, shading, ventilation, moisture-proofing, insect-proofing,
rodent-proofing, etc. shall be taken for storage of drugs according to requirements;
(V) Drug handling and stacking shall be performed strictly according to the requirements
indicated on external package and the Practice. Stacking height shall comply with the
requirements of packaging graphics and avoid damage to drug packaging;
(VI) Drugs shall be stacked by batch number. The drugs of different batch numbers shall not
be in a mixed pile. Pile spacing shall not be smaller than 5cm. The distance from the inner
wall, ceiling, temperature regulating equipment and pipeline, and other facilities within the
storeroom shall not be smaller than 30cm; and the distance from ground shall not be
smaller than 10cm;
(VII) Drugs and non-drugs, drugs for external use, and other drugs shall be stored
separately. Traditional Chinese medicinal materials and Chinese herbal medicines shall be
stored in different warehouses;

(VIII) The drugs under special control shall be stored according to relevant provisions of the
state;
(IX) Scattered drugs with the external packaging removed shall be centrally stored;
(X) The facilities and equipment for storing drugs such as shelf, tray, etc shall be kept clean,
without damage and dirt;
(XI) The unauthorized personnel shall not enter storage operation area. The personnel
within storage operation area shall not commit any act affecting drug quality and safety;
(XII) Drug storage operation area shall not store goods that are irrelevant to storage
management.
Article 86 Maintenance personnel shall conduct maintenance on drugs according to
storeroom conditions, external environment, quality characteristics of drugs, etc. Main
contents include:
(I) Direct and urge storage personnel to carry out rational storage and operation of drugs;
(II) Inspect and improve storage conditions, preventive measures, and the environment;
(III) Conduct effective monitoring and regulation on the temperature and humidity of
storeroom;
(IV) Conduct inspection on the appearance, packaging and other quality statuses of stored
drugs according to maintenance plan and establish maintenance record; conduct focused
maintenance on the variety with special requirements on storage conditions or shorter
period of validity;
(V) Timely lock and record the drug in question on the computer system and inform quality
management department of treatment;
(VI) Adopt effective methods to conduct maintenance and record of traditional Chinese
medicinal materials and Chinese herbal medicines according to their characteristics; the
maintenance methods adopted shall not cause contamination of the drugs;
(VII) Periodically summarize and analyze maintenance information.
Article 87 Enterprises shall adopt computer system to conduct automatic tracking and
control within the period of validity of stored drugs, take such measures as warning for
those nearing the end of period of validity and automatic locking of expired drugs, and
prevent sales of expired drugs.
Article 88 When liquid, gas, and powder leakage are caused due to the damage of drugs,
rapidly take safety and treatment measures and protect the storage environment and other
drugs from contamination.
Article 89 Sales suspension measures shall be taken immediately for drugs of suspicious
quality and such drugs shall be locked in the computer system and reported to quality
management department for confirmation. The following measures shall be taken for the

drugs with quality problems:

(I) Store in special place with obvious mark, take effective isolation measures, and shall not
be sold;
(II) The drugs suspected of being fakes shall be immediately reported to drug administrative
department;
(III) The drug under special control shall be treated according to the relevant provisions of
the state;
(IV) The treatment process of nonconforming drugs shall have complete procedures and
record;
(V) For nonconforming drugs, find out and analyze the reasons and timely take preventive
measures.
Article 90 Enterprises shall periodically take inventory of drugs stock and achieve
consistency between account and goods.
Section XI Sales
Article 91 Enterprises shall sell drugs only to lawful purchaser, verify the evidential
documents of purchaser, purchase personnel and the identification certificate of receiver,
and ensure the flow direction of drug sales to be authentic and legitimate.
Article 92 Enterprises shall strictly examine the production range, operation range or
diagnosis and treatment range of purchasing unit and sell drugs according to appropriate
range.
Article 93 Enterprises selling drugs shall issue invoices truthfully and achieve the
consistency among bill, account, goods, and amount of payment.
Article 94 Enterprises shall properly maintain the record of drug sales. Sales record shall
include the generic name of drug, specification, dosage form, batch number, period of
validity, manufacturer, purchasing unit, sales quantity, unit price, amount, selling date, and
other contents. For the drug under direct transfer according to the provisions in Article 69 of
the Practice, special sales record shall be established.
The sales record of traditional Chinese medicinal materials shall include name of product,
specification, producing area, purchasing unit, sales quantity, unit price, selling date, and
other contents; the sales record of Chinese herbal medicine shall include the name of
product, specification, batch number, producing area, manufacturer, purchasing unit, sales
quantity, unit price, amount, selling date, and other contents.
Article 95 Selling the drug under special control and the drug implementing the special

management requirements of the state shall strictly follow the relevant provisions of the
state.
Section XII

Delivery from Storage

Article 96 At the time of warehouse-out, the drugs shall be checked against sales record.
Warehouse-out shall not be conducted when the following circumstances are found and
reported to quality management department for treatment:
(I) Such problems as damage, pollution, insecure sealing, uncompacted liner, seal damage,
etc. are found on drug packaging;
(II) Abnormal noise or liquid leakage in package;
(III) Labels come off, the writing is illegible or the content of label is inconsistent with
physical goods;
(IV) The drug has exceeded the period of validity;
(V) Drugs in other abnormal conditions.
Article 97 Records shall be established for drug outbound review, including purchasing
unit, generic name of drug, dosage form, specification, quantity, batch number, valid period,
manufacturer, outbound date, quality condition, reviewer, and other contents.
Article 98 The outbound drugs under special control shall be reviewed according to
relevant provisions.
Article 99 Striking LCL mark shall be provided on the alternative packing box for delivery
of drug LCL.
Article 100 When drugs are delivered from storage, the accompanying bill (document)
affixed with the original special seal for outbound drugs of the enterprise shall be attached.
In case the enterprise directly transfers drugs according to the provisions in Article 69 of the
Practice, when direct transfer drug is delivered from storage, supplier shall issue two
accompanying bills (documents) and send to direct transfer enterprises and purchasing units
respectively. The contents of accompanying bill (document) shall meet the requirements in
Item II of Article 73 of this Practice and indicate the name of direct transfer enterprise.
Article 101 The encasement, loading and other operations of refrigerated and frozen
drugs shall be managed by dedicated person and meet the following requirements:
(I) Vehicle-mounted freezer or heat-insulated container shall meet relevant requirements on
temperature before use;
(II) The casing and sealing of refrigerated and frozen drugs shall be completed in cold
environment;

(III) The startup and operation status of refrigerated vehicle shall be checked before
loading. Loading shall not be conducted until the specified temperature is met;
(IV) Transportation records shall be made when shipment is started. The contents include
transportation means, time of shipment, etc.
Article 102 For the drugs under electronic supervision, the code shall be scanned and the
data shall be uploaded when the drugs are delivered from storage.
Section XIII Transportation and Delivery
Article 103 Enterprises shall strictly execute the operation procedures for transportation
according to the requirements of quality management system and take effective measures
to guarantee the quality and safety of drug during transportation.
Article 104 For transportation of drugs, appropriate transportation means shall be
selected according to the packaging and quality characteristics of drugs and taking into
account vehicle conditions, road, weather, and other factors. Appropriate measures shall be
taken to prevent damage, contamination, and other problems.
Article 105 When drugs are shipped, the transportation means shall be checked. Drugs
shall not be shipped if the transportation conditions do not comply with provisions. During
transportation of drugs, the delivery vehicle shall be kept tightly closed.
Article 106 Enterprises shall perform and loading and unloading drugs strictly according to
the requirements indicated on external package.
Article 107 Enterprises shall take necessary heat preservation or refrigeration and
freezing measures during transportation according to the requirements on the temperature
control of drugs.
During transportation, drugs shall not directly contact ice bag, ice raft, and other coolants to
protect the quality of drugs from being impacted.
Article 108 During the transportation of refrigerated and frozen drugs, the temperature
data of refrigerator vehicle and frozen container or heat-insulating container shall be
monitored and recorded in real time.
Article 109 Enterprises shall formulate the contingency plan on the transportation of
refrigerated and frozen drugs and take appropriate corresponding measures for the
emergencies that could occur during transportation, such as equipment failure, abnormal

weather impact, traffic jam, etc.

Article 110 If other units are authorized to transport drugs, enterprises shall audit the
quality assurance ability of carrier in transportation of drugs, and ask for the materials
relating to transportation vehicles. Only the units complying with the conditions and
requirements of the transportation facilities and equipment in the Practice may be
authorized.
Article 111 Enterprises authorizing transportation of drugs shall sign transportation
agreement with carrier, and clearly define the contents such as responsibility for the quality
of drug, operation procedures that have to be observed during transportation, transportation
time, etc.
Article 112 Enterprises authorizing the transportation of drugs shall maintain the record
and achieve the quality traceability during transportation. The record shall at least include
time of delivery, delivery address, receiving unit, receiving address, waybill number, the
number of cases of drugs, way of transportation, authorized handler, and carrier unit. If
vehicles are used for transportation, the record shall also specify license plate number and
keep the copy of the driving license of driver. The record shall be kept at least for 5 years.
Article 113 Loaded drugs shall be timely shipped and delivered as quickly as possible. In
case of authorized transportation, enterprises shall ask and supervise the carrier to strictly
perform the authorized transportation agreement and prevent the quality of drug from being
affected due to lengthy transit time.
Article 114 Enterprises shall adopt measures for transportation safety management and
protect drugs from robbery, loss, misplacement and other accidents during transportation.
Article 115 The transportation of the drugs under special control shall meet the relevant
provisions of the state.

Section XIV After-sales Management

Article 116 Enterprises shall strengthen the management on return of goods, ensure the
quality and safety of drugs in the link of return of goods, and prevent mixing with
counterfeit drugs.
Article 117 Enterprises shall formulate the operation procedures for complaint
management according to the requirements of quality management system. The contents
include complaint channel and way, archival record, investigation and evaluation, treatment

measures, feedback and post-event tracking, etc.

Article 118 Enterprises shall allocate full-time or part-time personnel in charge of aftersales complaint management, investigate the causes of the quality problem causing
complaints, take effective measures to perform timely treatment and feedback, and properly
make records; if necessary, inform supplier and drug manufacturing enterprise.
Article 119 Enterprises shall timely record such information as complaints and treatment
results into files for the convenience of inquiry and tracking.
Article 120 Enterprises, if severe quality problem is found for the drugs sold, shall
immediately notify purchasing unit to stop selling, take back the drugs, and make proper
record; and report to drug administration department at the same time.
Article 121 Enterprises shall assist drug manufacturing enterprises in performing the
obligation for recall, timely communicate and transmit drug recall information according to
the requirements on recall plan, control and take back the drugs which have potential safety
hazards, and establish the record of drug recall.
Article 122 The quality management department of enterprise shall allocate full-time or
part-time personnel and undertake the monitoring and reporting of adverse reactions of
drugs according to the relevant provisions of the state.
Chapter III Quality Management for Retail of Pharmaceutical Products
Section I Quality Management and Responsibility
Article 123 Enterprises shall formulate quality management document according to the
relevant laws and regulations and the requirements of this Practice, carry out quality
management activities, and ensure the quality of drugs.
Article 124 Enterprises shall have the operation conditions that match the scope of
business and scale, including organization, personnel, facilities and equipment, quality
management document, and set computer system according to provisions.
Article 125 Enterprises responsible person is the primary responsible person of drug
quality, and is comprehensively responsible for the daily management of the enterprise and
for providing necessary conditions, ensuring that the quality management department and
quality management personnel effectively perform their duties, and that the enterprise
distributes drugs according to the requirements of this Practice.

Article 126 Enterprises shall establish quality management department or allocate quality
management personnel to perform the following responsibilities:
(I) Urge the personnel of relevant departments and posts to execute the laws and
regulations for drug management and this Practice;
(II) Organize the formulation of quality management system document and guide and
supervise the execution of the document;
(III) Audit the qualification certificate of supplier and its sales personnel;
(IV) Audit the legality of the drug purchased;
(V) Perform drug acceptance; direct and supervise the quality management in the links of
drug purchase, storage, display, sales, etc.;
(VI) Perform drug quality inquiry and quality information management;
(VII) Investigate, handle and report drug quality complaints and quality accidents;
(VIII) Verify and handle nonconforming drugs;
(IX) Report counterfeit and low-quality drugs;
(X) Report adverse reactions to drugs;
(XI) Carry out the education and training of drug quality management;
(XII) Authenticate and control the operating authority of computer system and the
maintenance of quality management basic data;
(XIII) Organize the calibration and verification of measuring instruments;
(XIV) Direct and supervise pharmaceutical service;
(XV) Other responsibilities to be performed by quality management department or quality
management personnel.
Section II Personnel Management
Article 127 The personnel of enterprise engaging in drugs-related operations and quality
management shall comply with the requirements of relevant laws and regulations and this
Practice on qualification and shall not engage in any practice prohibited by relevant laws and
regulations.
Article 128 The legal representative or responsible person of the enterprise shall have the
qualification of licensed pharmacist.

Enterprises shall allocate licensed pharmacist according to the relevant provisions of the
state, who will be responsible for prescription checking and directing rational drug use.
Article 129 Quality management, acceptance, and purchasing personnel shall have the
educational background in relevant disciplines such as pharmacy or medicine, biology,
chemistry, etc. or the professional technical title in pharmacy. The quality management,
acceptance, and purchasing personnel dealing with in Chinese herbal medicine shall have

the educational background above the professional secondary technical school in the science
of Chinese pharmacology or the professional technical title above the primary level in
pharmacy.
Shop assistant shall have the degree of education above senior high school or meet the
conditions specified by provincial drug administration department. The dispenser of Chinese
herbal medicine shall have the educational background above professional technical
secondary school in the science of Chinese pharmacology or the qualification of TCM
dispenser.
Article 130 The personnel of enterprises on each post shall receive the pre-job training
and continuing training on relevant laws and regulations and the professional knowledge and
skills on drugs to meet the requirements of this Practice.
Article 131 Enterprises shall formulate annual training plan and carry out training
according to training management system and enable relevant personnel to correctly
understand and perform their responsibilities. Training work shall be properly recorded and
files shall be created.
Article 132 Enterprises shall provide the conditions to the personnel selling the drugs
under special control and the drugs and refrigerated drugs with special management
requirements to receive appropriate training and enable them to grasp relevant laws and
regulations and professional knowledge.
Article 133 The working personnel of enterprises shall wear clean and sanitary work
clothes within the workplace.
Article 134 Enterprises shall provide pre-job and annual health examination to the
personnel on the jobs in which they could directly contact the drugs and establish health
record. Personnel suffering from infectious diseases or other diseases that could
contaminate drugs shall not engage in the work in which they could directly contact the
drugs.
Article 135 The articles and personal effects irrelevant to operation activities shall not be
stored in drug storage and display areas. No act affecting the quality and safety of drugs
shall be committed in the work area.
Section III Documents
Article 136 Enterprises shall formulate the quality management documents meeting the
actual situations of the enterprises according to the relevant laws and regulations and the

provisions of this practice. The documents shall include quality management system, job
responsibilities, operation procedures, files, records, vouchers, etc. Quality management
documents shall be periodically audited and timely revised.
Article 137 Enterprises shall take measures to ensure that the personnel on each post
correctly understand the contents of the quality management document and ensure that the
quality management document is effectively executed.
Article 138 The quality management system for drug retail shall include the following
contents:
(I) Management on drug purchase, acceptance, display, sales, and other links; also include
storage and maintenance management when storeroom is arranged;
(II) Audit of supplier and purchased variety;
(III) Management of prescription drug sales;
(IV) Drug dividing management;
(V) Management on the drugs under special control and the drugs with special management
requirement of the state;
(VI) Management of records and vouchers;
(VII) Management on collecting and inquiring about quality information;
(VIII) Management of quality accidents and quality complaints;
(IX) Management on the prescription checking, dispensing and verification of Chinese herbal
medicines;
(X) Management on period of validity of drugs;
(XI) Management on nonconforming drugs and drug destruction;
(XII) Provisions on environmental sanitation and personal health;
(XIII) Management on providing medication consultation, directing rational drug use, and
pharmaceutical services;
(XIV) Provisions on personnel training and assessment;
(XV) Provisions on reporting adverse reactions to drugs;
(XVI) Management of computer system;
(XVII) Provisions on execution of drug electronic supervision;
(XVIII) Other contents to be stipulated.
Article 139 Enterprises shall explicitly define the responsibilities of such posts as
enterprises responsible person, quality management, purchase, acceptance, shop
assistance, prescription checking, dispensing, etc., and also include the responsibilities of
storage and maintenance posts if storeroom is arranged.
Article 140 The responsibilities of quality management post and prescription checking

post shall not be performed by the personnel on other posts on their behalf.
Article 141 The operation procedures for drug retail shall include:
(I) Drug purchase, acceptance, and sales;
(II) Prescription checking, dispensing and verification;
(III) Prescription checking, dispensing and verification of Chinese herbal medicine;
(IV) Piecemeal sales;
(V) Sales of the drugs under special control and the drugs with special management
requirements of the state;
(VI) Drug display and inspection at business place;
(VII) Storage of drugs in cold storage at business place;
(VIII) Operation and management of computer system;
(IX) Also include the operation procedures for storage and maintenance if storeroom is
arranged.
Article 142 Enterprises shall establish the record relating to drug purchase, acceptance,
sales, display and inspection, temperature and humidity monitoring, nonconforming drug
disposal, etc. and ensure authenticity, integrity, accuracy, validity, and traceability.
Article 143 Records and relevant vouchers shall be kept at least for 5 years. The records
and vouchers of the drugs under special control shall be kept according to relevant
provisions.
Article 144 When data are recorded through computer system, the personnel on relevant
posts shall login on the computer system through authorization and password according to
the operation procedures to enter data and ensure that the data are original, authentic,
accurate, secure, and traceable.
Article 145 Electronic recording data shall be backed up in a secure and reliable way.
Section IV Facilities and Equipment
Article 146 The business place of enterprise shall be appropriate for the operation scope
and operation scale of drugs and be separated from drug storage, office, auxiliary living
area, and other areas.
Article 147 Business place shall have appropriate facilities or take other effective
measures, protect the drugs from impacts of outdoor environment, and shall be spacious,
bright, clean, and sanitary.
Article 148 Business place shall have the following business equipment:

(I) Shelf and counter;

(II) Equipment for monitoring and regulating temperature;
(III) Equipment for storing medicinal slices and prescription dispensing for Chinese herbal
medicine;
(IV) Special cold storage equipment for drugs requiring refrigeration;
(V) Special storage equipment meeting safety provisions for Category II psychotropic drugs,
toxic traditional Chinese medicine, and poppy shell;
(VI) Dispensing tools and packaging supplies necessary for piecemeal sales.
Article 149 Enterprises shall establish the computer system complying with the
requirements on operation and quality management and meet the conditions for
implementing drug electronic supervision.
Article 150 If enterprises arrange warehouse, the internal wall and ceiling of warehouse
shall be smooth and clean. The ground shall be leveled. The structure of doors and windows
shall be tight; and reliable safety, protection, and anti-theft measures shall be taken.
Article 151

The following facilities and equipment shall be provided for warehouse:

(I) Equipment for effective isolation between drugs and ground;

(II) Equipment for light-proofing, ventilation, moisture-proofing, insect-proofing, rodentproofing, etc.;
(III) Equipment for effectively regulating temperature and humidity and the indoor and
outdoor air exchange;
(IV) Lighting equipment meeting the requirements on storage operation;
(V) Special place for acceptance;
(VI) Special storage place for nonconforming drugs; and
(VII) Storage facilities conforming to the national provisions for drugs under special control
if they require refrigeration.
Article 152 The drugs under special control shall be provided with the storage facilities
meeting the national provisions.
Article 153 Special warehouse shall be established for storage of Chinese herbal medicine.
Article 154 Enterprises shall perform calibration or verification of measuring instruments,
temperature and humidity monitoring equipment, etc. periodically according to the relevant
provisions of the state.
Section V Purchase and Acceptance
Article 155 Enterprises purchasing drugs shall meet the relevant provisions in Section

VIII, Chapter II of this Practice.

Article 156 When drugs arrive, receivers shall verify the physical drugs against the
accompanying bills (documents) according to purchase record and ensure the consistency
among bill, account, and goods.
Article 157 Enterprises shall conduct batch-to-batch sampling acceptance for the drugs
arrived according to specified procedures and requirements and properly make acceptance
record according to the provisions in Article 80 of this Practice.
The samples drawn shall be representative.
Article 158 When refrigerated and frozen drugs arrive, inspection shall be conducted
according to the provisions in Article 74 of this Practice.
Article 159

The inspection report on drugs shall be checked during the acceptance of

drugs according to the provisions in Article 76 of this Practice.

Article 160 The drugs under special control shall be accepted according to relevant
provisions.
Article 161 The drugs accepted as qualified shall be timely warehoused or put on shelf.
Also, for drugs for which electronic supervision is implemented, the code shall be scanned
and data shall be uploaded according to the provisions in Article 81 and Article 82 of this
Practice. The drugs identified as unqualified during acceptance shall not be warehoused or
put on shelf but reported to quality management personnel for treatment.

Section VI Display and Storage

Article 162 Enterprises shall monitor and regulate the temperature of business place so as
to ensure that the temperature at the business place meets the requirements on normal
temperature.
Article 163 Enterprises shall periodically conduct sanitary inspection and keep the
environment clean. The equipment for storing and displaying drugs shall be kept clean and
sanitary without placing articles irrelevant to sales activities on them. Insect-proofing,
rodent-proofing, and other measures shall be taken to prevent contamination of drugs.
Article 164 The display of drugs shall meet the following requirements:
(I) Classify and display drugs by dosage form, purpose, and storage requirements and set

highly visible symbol; the category label shall be legible and the placement shall be
accurate;
(II) Drugs are placed on storage shelf (cabinet) and placed in good order, and kept away
from direct sunlight;
(III) Prescription drugs and non-prescription drugs shall be displayed in separate zones and
attached with special mark of prescription drug and non-prescription drug;
(IV) Prescription drugs shall not be displayed and sold by way of open-shelf and selfselection;
(V) Drugs for external use shall be separated from other drugs when placing;
(VI) The drugs for piecemeal sales shall be placed in special cabinet or zone;
(VII) Category II psychotropic drug, toxic traditional Chinese medicine, and poppy shell shall
not be displayed;
(VIII) Drugs requiring refrigeration shall be placed in refrigeration equipment; monitoring
and recording of temperature shall be conducted according to provisions; and the storage
temperature shall meet requirements;
(IX) Correct name and regular script shall be written on the position of Chinese herbal
medicine cabinet; before loading, carefully check and prevent wrong loading and tainting;
periodically clean the drawer and protect the medicinal slices from hemiparasite, mildew,
and deterioration; the drawer shall be cleaned and recorded before loading the medicinal
slices in different batch numbers;
(X) Special zone shall be arranged for the handling of non-drug articles, which shall be
isolated from drug area and attached with visible signs.
Article 165 Enterprises shall periodically conduct inspection on the drugs displayed and
stored, with the focus on the inspection of drugs for piecemeal sales and the drugs that
easily deteriorate, those that will expire soon, those that have been placed for a long time,
or Chinese herbal medicine. If the drugs with quality problems are found, such drugs shall
be removed from the cabinet and their sales shall be stopped. Such drugs shall be verified
and treated by quality management personnel and relevant record shall be kept.
Article 166 Enterprises shall conduct tracking management on the period of validity of
drugs and prevent sales of drugs nearing their expiry date usage of expired drugs.
Article 167 If enterprises arrange warehouse, the drug storage and maintenance
management of warehouse shall meet the relevant provisions in Section X of Chapter II of
this practice.
Section VII Sales Management
Article 168 Enterprises shall hang pharmaceutical operation license, business license,

licensed pharmacist registration certificate, etc. at conspicuous spots in the business place.
Article 169 Sales personnel shall wear the work card with photo, name, post, and other
contents; if they are licensed pharmacist and pharmaceutical technical personnel, the work
card shall also indicate the certificate of competence or professional technical title in
pharmacy. The licensed pharmacists on duty shall wear their work cards.
Article 170 The sales of drugs shall meet the following requirements:
(I) Prescription shall not be blended until examined and approved by licensed pharmacist;
the drugs listed on prescription shall not be changed or replaced without authorization;
blending of the prescription with incompatibility or chance of overdosing shall be refused,
unless corrected or signed again by prescribing physician; and the prescription blended may
not be sold after being checked;
(II) Prescription review, blending, and check personnel shall sign or affix seal on the
prescription and store the prescription or its copy according to relevant provisions;
(III) In case of sales of near-end-of-validity drugs, inform customer of the period of validity;
(IV) The measure of the Chinese herbal medicine to be sold shall be accurate and the
decoction method and precautions shall be informed; provide decoction service for Chinese
herbal medicine and conform to the relevant provisions of the state.
Article 171 Enterprises selling drugs shall issue sales vouchers. The contents include the
name of drug, manufacturer, quantity, price, batch number, specification, etc. and properly
make sales record.
Article 172 The piecemeal sales of drugs shall meet the following requirements:
(I) The personnel responsible for piecemeal sales have received special training;
(II) The workbench and tools for dividing shall be kept clean and sanitary and prevent cross
contamination;
(III) Properly make piecemeal sales record. The contents include the starting and ending
dates of piecemeal sales, generic name of drug, specification, batch number, manufacturer,
period of validity, sales quantity, dividing reviewer, etc.;
(IV) Piecemeal sales shall use clean and sanitary package. The package shall indicate the
name of drug, specification, quantity, usage, dosage, batch number, period of validity, and
name of drugstore, and other contents;
(V) Provide the originals or copies of drug instructions; and
(VI) Retain the original package and instructions during piecemeal sales period.
Article 173 The sales of the drugs under special control and the drugs with special
management requirements of the state shall strictly follow the relevant provisions of the

state.
Article 174 Drug advertisement and publicity shall strictly follow the provisions of the
state on advertisement management.
Article 175 The on-the-job staff of other enterprises shall not engage in the activities
relating to drug sales within the business place.
Article 176 For the drugs under electronic supervision, the code shall be scanned and the
data shall be uploaded when the drugs are sold.

Section VIII After-sales Management

Article 177 Except for the reasons of drug quality, drugs shall not be returned or replaced
once sold.
Article 178 Enterprises shall publish monitoring telephone of food and drug administration
department at business place, arrange customers complaint book, and timely handle the
complaints of customers on drug quality.
Article 179 Enterprises shall collect and report information about drug adverse reaction to
drugs according to the provisions of the state on reporting system for adverse reactions to
drugs.
Article 180 Enterprises, whenever severe quality problem is found for the drugs sold, shall
timely take measures to take back the drugs and make proper record; at the same time,
report to food and drug administrative department.
Article 181 Enterprises shall assist drug manufacturing enterprise in performing the
obligations for recall, control and take back the drugs which have potential safety hazards,
and establish drug recall record.

Chapter IV Supplementary Provisions

Article 182 The management of the head office of drug retail chain enterprise shall meet
the relevant provisions of this Practice on drug wholesale enterprises. The management of
retail store shall meet the relevant provisions of this Practice on drug retail enterprises.
Article 183 This practice is the basic requirement of good supply practice for

pharmaceutical products. The specific requirements on enterprise informatization

management, automatic monitoring of the temperature and humidity for drug storage and
transportation, drug acceptance management, drug cold chain logistics management, retail
chain management, etc. shall be formulated by China Food and Drug Administration by way
of appendix separately.
Article 184 The terms referred in this Practice shall have the following meanings:
(I) On the job: Personnel on the payroll with established labor relations with enterprise.
(II) On duty: Perform duties by the personnel of relevant post at specified post during work
time.
(III) First commercial enterprise: Drug manufacturing or operating enterprise which has first
supply-demand relation with the enterprise when drugs are purchased.
(IV) First commercial varieties: Drugs first purchased by the enterprise.
(V) Original seal: Original mark of enterprises official seal, special seal for invoice, special
seal for quality management, and special seal for drug delivery affixed on relevant document
or certificate for certifying the identity of enterprise during the purchasing and sales
activities of enterprise, other than the stamp after duplication by printing, photocopying,
copying, etc.
(VI) Quarantine: The status of the drugs that have arrived or are returned after selling,
isolated or distinguished in effective way, and waiting for quality acceptance before
warehousing.
(VII) Scattered goods: Refer to the drugs with the package for transportation and storage
removed.
(VIII) LCL shipping: The way of piecing scattered drugs together into the same packaging
box for shipping.
(IX) Piecemeal sales: The way of sales by further dividing the minimum package.
(X) Drug with special management requirement of the state: The drugs that the state
implementing special administrative measures on such variety as anabolic agent, peptide
hormone, compound preparation containing special drug, etc.
Article 185 The good manufacturing practice for the purchase, storage, maintenance, etc.
of the drugs for the dispensary of medical institutions and family planning technical service
institutions shall be formulated by China Food and Drug Administration by consulting
relevant competent departments separately.
The provisions on the quality management of the drugs sold online shall be formulated by
China Food and Drug Administration separately.
Article 186 If drug distributors violate this practice, punishment shall be imposed by food
and drug administrative department in accordance with the provisions in Article 79 of the

Pharmaceutical Administration Law of the Peoples Republic of China.

Article 187 This Practice shall come into force on June 1, 2013. In accordance with the
provisions of Article 16 of the Pharmaceutical Administration Law of the Peoples Republic of
China, the specific implementation measures and procedures shall be stipulated by China
Food and Drug Administration