Good Management Practice for Pharmaceutical Trading

Quality Management Standards for Pharmaceutical Trading (Decree No. 90 of the Ministry of Health)
National Health and Family Planning Commission of the People's Republic of China www.moh.gov.cn
No. 90

 

The "Standards for the Quality Control of Pharmaceutical Trading", which were reviewed and adopted by the Ministry of Health on November 6, 2012, are hereby promulgated and will come into force as of June 1, 2013.

 

 

Minister Chen Zhu
January 22, 2013

 

 

 

 

Article 1 These Regulations are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China and the Regulations for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China in order to strengthen the quality control of pharmaceutical trading, standardize pharmaceutical trading behavior, and ensure the safety and effectiveness of drug use by human beings.
Article 2 These Standards are the basic guidelines for drug trade management and quality control. Enterprises should take effective quality control measures in the procurement, storage, sales, transportation and other links of drugs to ensure the quality of drugs.
Article 3 Pharmaceutical trading enterprises shall strictly implement these Regulations.
The drug manufacturers shall also comply with the relevant requirements of this Code if they are involved in the storage and transportation of drugs during the sale and circulation of drugs.
Article 4 Pharmaceutical trading enterprises shall adhere to honesty and trustworthiness and operate according to law. Any false or deceptive behavior is prohibited.

 

 

 

 

Section I Quality Management System
Article 5 An enterprise shall establish a quality management system, determine quality policies, formulate quality management system documents, and carry out quality planning, quality control, quality assurance, quality improvement, quality risk management and other activities in accordance with relevant laws and regulations and the requirements of this Code.
Article 6 The quality policy document formulated by the enterprise shall specify the overall quality objectives and requirements of the enterprise and shall be implemented throughout the whole process of drug trading activities.
Article 7 The quality management system of an enterprise shall adapt to its business scope and scale, including organization, personnel, facilities and equipment, quality management system documents and corresponding computer systems.
Article 8 An enterprise shall organize internal audit regularly and when the key elements of the quality management system change significantly.
Article 9 An enterprise shall analyze the internal audit, formulate corresponding improvement measures for the quality management system according to the analysis conclusions, continuously improve the quality control level, and ensure the continuous and effective operation of the quality management system.
Article 10 An enterprise shall adopt a forward-looking or retrospective approach to assess, control, communicate and review the quality risks in the process of drug distribution.
Article 11 An enterprise shall evaluate the quality management system of drug suppliers and purchasers, confirm their quality assurance ability and reputation, and conduct on-site inspection when necessary.
Article 12 An enterprise shall participate in the quality management with all its members. All departments and post personnel shall correctly understand and perform their duties and assume corresponding quality responsibilities.

 

 

 

Section II Organizational Structure and Quality Management Responsibilities
Article 13 An enterprise shall establish an organizational structure or post appropriate to its business activities and quality management, and clearly define its responsibilities, authorities and interrelationships.
Article 14 The person in charge of an enterprise is the main person responsible for the quality of drugs, who is fully responsible for the daily management of the enterprise, is responsible for providing the necessary conditions, ensuring that the quality management departments and quality management personnel effectively perform their duties, ensuring that the enterprise achieves its quality objectives and handles drugs in accordance with the requirements of this Code.
Article 15 The person in charge of the quality of an enterprise shall be a senior manager, who shall be fully responsible for the drug quality management, perform his duties independently, and have the power of adjudication on drug quality management within the enterprise.
Article 16 An enterprise shall establish a quality control department to effectively carry out quality control. The responsibilities of the quality management department shall not be performed by other departments and personnel.
Article 17 The quality management department shall perform the following duties:
（1） Supervise and urge relevant departments and personnel to implement the laws, regulations and this specification on drug management;
（2） Organize the preparation of quality management system documents, and guide and supervise the implementation of documents;
（3） Be responsible for reviewing the legitimacy of the supplier and purchaser, the legitimacy of the drugs purchased, and the legal qualifications of the sales personnel of the supplier and the purchaser, and conduct dynamic management according to the changes in the review content;
（4） Be responsible for the collection and management of quality information and the establishment of drug quality archives;
（5） Be responsible for the acceptance of drugs, guide and supervise the quality management of drug procurement, storage, maintenance, sales, return, transportation and other links;
（6） Be responsible for the confirmation of unqualified drugs, and supervise the handling process of unqualified drugs;
（7） Be responsible for the investigation, handling and reporting of drug quality complaints and quality accidents;
（8） Be responsible for the report of fake and substandard drugs;
（9） Be responsible for drug quality inquiry;
（10） Be responsible for guiding the setting of computer system quality control functions;
（11） Be responsible for the review of computer system operation authority and the establishment and update of basic quality management data;
（12） Organize verification and calibration of relevant facilities and equipment;
（13） Be responsible for the management of drug recall;
（14） Responsible for reporting adverse drug reactions;
（15） Organize the internal audit and risk assessment of the quality management system;
（16） Organize the inspection and evaluation of the quality management system and service quality of drug suppliers and purchasers;
（17） Organize the review of the transportation conditions and quality assurance capability of the entrusted carrier;
（18） Assist in quality management education and training;
（19） Other responsibilities that should be performed by the quality management department.

 

 

 

Section III Personnel and Training
Article 18 The personnel engaged in drug trading and quality management of the enterprise shall meet the qualification requirements specified in relevant laws and regulations and this Code, and shall not be prohibited from working by relevant laws and regulations.
Article 19 The person in charge of an enterprise shall have a college degree or above or a professional technical title at or above the intermediate level, have received training in basic pharmaceutical expertise, and be familiar with the laws, regulations and the present Code on drug administration.
Article 20 The person in charge of the quality of an enterprise shall have a bachelor's degree or above, the qualification of a licensed pharmacist, and more than three years of experience in the quality management of drug distribution, and the ability to correctly judge and guarantee the implementation of quality management.
Article 21 The person in charge of the quality management department of an enterprise shall have the qualification of a licensed pharmacist and more than three years of experience in the quality management of drug distribution, and be able to independently solve quality problems in the course of drug distribution.
Article 22 An enterprise shall be staffed with quality management, acceptance and maintenance personnel who meet the following qualification requirements:
（1） Those who are engaged in quality management should have a secondary technical school degree in pharmacy or a college degree or above in medicine, biology, chemistry or other related majors, or have a professional technical title at or above the junior level in pharmacy;
（2） Those who are engaged in acceptance and maintenance work shall have a secondary technical school degree or above in pharmacy or medicine, biology, chemistry or other related majors, or have a professional technical title at or above the junior level in pharmacy;
（3） Those who are engaged in the inspection and acceptance of traditional Chinese medicine and prepared slices of traditional Chinese medicine shall have a secondary technical school degree or above in the specialty of traditional Chinese medicine or have a professional technical title or above in the specialty of traditional Chinese medicine; Those who are engaged in the maintenance of traditional Chinese medicines and prepared slices of traditional Chinese medicine shall have a secondary technical school degree or above in the specialty of traditional Chinese medicine or a professional technical title at or above the junior level in the specialty of traditional Chinese medicine; In the case of direct purchase of Chinese medicinal materials in the real estate, the inspectors shall have professional and technical titles at or above the intermediate level of Chinese pharmacy.
An enterprise engaged in vaccine business shall also have at least two professional technicians specially responsible for vaccine quality management and acceptance. The professional technicians shall have a bachelor's degree or above in preventive medicine, pharmacy, microbiology or medicine and a professional technical title or above at the intermediate level, and have more than three years of experience in vaccine management or technical work.
Article 23 The personnel engaged in quality management and acceptance inspection shall be on duty and shall not concurrently work in other businesses.
Article 24 Personnel engaged in procurement work shall have a secondary technical school education or above in pharmacy or medicine, biology, chemistry and other related majors, and personnel engaged in sales, storage and other work shall have a high school education or above.
Article 25 The enterprise shall carry out pre job training and continuing training for personnel at all posts related to their duties and work contents to meet the requirements of this Code.
Article 26 The training contents shall include relevant laws and regulations, pharmaceutical professional knowledge and skills, quality management system, responsibilities and post operating procedures, etc.
Article 27 An enterprise shall, in accordance with the training management system, formulate an annual training plan and carry out training so that relevant personnel can correctly understand and perform their duties. The training work shall be recorded and archived.
Article 28 Personnel engaged in the storage and transportation of drugs under special management and refrigerated and frozen drugs shall receive training in relevant laws, regulations and professional knowledge and pass the examination before taking up their posts.
Article 29 The enterprise shall formulate a personal hygiene management system for its employees, and the clothes of personnel in storage, transportation and other posts shall meet the requirements of labor protection and product protection.
Article 30 Personnel in positions directly in contact with drugs, such as quality management, acceptance, maintenance and storage, shall undergo pre post and annual health examinations and establish health records. Those who suffer from infectious diseases or other diseases that may contaminate drugs may not engage in work that directly contacts drugs. Those whose physical conditions do not meet the specific requirements of corresponding posts shall not be engaged in relevant work.

 

 

 

Section IV Quality Management System Documents
Article 31 The quality management system documents formulated by an enterprise shall conform to the actual situation of the enterprise. The documents include quality management system, department and post responsibilities, operating procedures, archives, reports, records and vouchers.
Article 32 The drafting, revision, review, approval, distribution, storage, modification, cancellation, replacement and destruction of documents shall be carried out in accordance with the document management operating procedures, and relevant records shall be kept.
Article 33 The title, category, purpose, document number and version number shall be indicated in the document. The words shall be accurate, clear and easy to understand. Documents shall be classified and stored for easy reference.
Article 34 An enterprise shall regularly review and revise its documents, and the documents used shall be the currently valid ones. The obsolete or invalid documents shall not appear on the work site except for keeping files for future reference.
Article 35 The enterprise shall ensure that all posts obtain the necessary documents corresponding to their work contents, and carry out their work in strict accordance with the regulations.
Article 36 The quality management system shall include the following contents:
（1） Regulations on internal audit of quality management system;
（2） Provisions on quality veto;
（3） Management of quality management documents;
（4） Management of quality information;
（5） Provisions on qualification review of suppliers, purchasers, sales personnel of suppliers and purchasers;
（6） Management of drug procurement, receipt, acceptance, storage, maintenance, sales, ex warehouse and transportation;
（7） Provisions on drugs under special control;
（8） Management of drug validity;
（9） Management of unqualified drugs and destruction of drugs;
（10） Management of drug returns;
（11） Management of drug recall;
（12） Quality query management;
（13） Management of quality accidents and complaints;
（14） Provisions on adverse drug reaction reports;
（15） Provisions on environmental sanitation and personnel health;
（16） Regulations on quality education, training and assessment;
（17） Management of facilities and equipment storage and maintenance;
（18） Management of verification and calibration of facilities and equipment;
（19） Management of records and vouchers;
（20） Management of computer system;
（21） Implement the provisions on electronic drug supervision;
（22） Other contents that should be specified.
Article 37 Department and post responsibilities shall include:
（1） Responsibilities of quality management, procurement, storage, sales, transportation, finance and information management departments;
（2） Job responsibilities of the person in charge of the enterprise, the person in charge of quality and the person in charge of quality management, procurement, storage, sales, transportation, finance and information management departments;
（3） Responsibilities of quality management, procurement, receiving, acceptance, storage, maintenance, sales, ex warehouse review, transportation, finance, information management and other posts;
（4） Other job responsibilities related to drug distribution.
Article 38 An enterprise shall formulate operating procedures for drug procurement, receipt, acceptance, storage, maintenance, sales, ex warehouse review, transportation and other links as well as computer systems.
Article 39 An enterprise shall establish records related to the purchase, acceptance, maintenance, sales, ex warehouse review, return after sales, purchase and withdrawal, transportation, storage and transportation temperature and humidity monitoring, and disposal of unqualified drugs, so as to be true, complete, accurate, effective, and traceable.
Article 40 When recording data through the computer system, the relevant personnel shall, in accordance with the operating procedures, log in through authorization and password before entering or reviewing the data; The change of data shall be reviewed and supervised by the quality management department, and the change process shall be recorded.
Article 41 Written records and vouchers shall be filled in timely and legible, and shall not be altered or torn at will. If the record is altered, the reason, date and signature shall be indicated to keep the original information clear and legible.
Article 42 Records and vouchers shall be kept for at least 5 years. Records and vouchers of vaccines and specially managed drugs shall be kept according to relevant regulations.

 

 

 

Section V Facilities and Equipment
Article 43 An enterprise shall have a place of business and a warehouse appropriate to its drug business scope and scale.
Article 44 The site selection, design, layout, construction, transformation and maintenance of warehouses shall meet the requirements for drug storage and prevent drug contamination, cross contamination, confusion and errors.
Article 45 The drug storage operation area and auxiliary operation area shall be separated from the office area and living area at a certain distance or have isolation measures.
Article 46 The size and conditions of the warehouse shall meet the requirements of rational and safe storage of drugs, and meet the following requirements to facilitate the storage operation:
（1） The internal and external environment of the warehouse is clean and tidy, without pollution sources, and the ground in the warehouse area is hardened or greened;
（2） The internal wall and top of the warehouse are smooth, the ground is flat, and the doors and windows are tight;
（3） The warehouse has reliable safety protection measures, which can control the entry of irrelevant personnel to prevent drugs from being stolen, replaced or mixed with counterfeit drugs;
（4） Measures shall be taken to prevent outdoor loading and unloading, handling, receiving, shipping and other operations from being affected by abnormal weather.
Article 47 The warehouse shall be equipped with the following facilities and equipment:
（1） Equipment effectively isolated from the ground;
（2） Light proof, ventilated, moisture-proof, insect proof, rat proof and other equipment;
（3） Equipment for effective control of temperature and humidity and indoor and outdoor air exchange;
（4） Equipment for automatic monitoring and recording of temperature and humidity in the warehouse;
（5） Lighting equipment meeting the requirements of storage operation;
（6） Operation area and equipment for picking, LCL shipment and recheck;
（7） Storage place for packaging materials;
（8） Special places for acceptance, delivery and return;
（9） Special storage place for unqualified drugs;
（10） The drugs under special control shall have storage facilities that conform to the provisions of the State.
Article 48 Those who deal in traditional Chinese medicine and prepared slices of traditional Chinese medicine should have dedicated warehouses and maintenance workplaces, and those who directly purchase local traditional Chinese medicine should set up sample rooms (cabinets) for traditional Chinese medicine.
Article 49 Those who trade in refrigerated or frozen pharmaceuticals shall be equipped with the following facilities and equipment:
（1） For the cold storage appropriate to its business scale and variety, the vaccine operator shall be equipped with more than two independent cold storage;
（2） Equipment used for automatic temperature monitoring, display, recording, regulation and alarm of cold storage;
（3） Standby generator set or double circuit power supply system of refrigeration equipment in cold storage;
（4） For drugs with special low temperature requirements, facilities and equipment that meet their storage requirements shall be provided;
（5） Refrigerator truck, vehicle mounted refrigerated box or incubator and other equipment.
Article 50 Closed means of transport shall be used for drug transportation.
Article 51 The refrigerated vehicle, vehicle mounted refrigerated box and insulated box for transporting refrigerated and frozen drugs shall meet the requirements for temperature control during drug transportation. The refrigerated truck has the functions of automatic temperature control, temperature display, storage and reading of temperature monitoring data; Refrigerator and incubator have the function of external display and collection of temperature data inside the box.
Article 52 The regular inspection, cleaning and maintenance of storage and transportation facilities and equipment shall be in the charge of specially assigned persons, and records and archives shall be established.
Section VI Calibration and Verification
Article 53 Enterprises shall, in accordance with the relevant provisions of the State, regularly calibrate or verify measuring instruments, temperature and humidity monitoring equipment, etc.
The enterprise shall verify the facilities and equipment such as the cold storage, storage and transportation temperature and humidity monitoring system, and refrigerated transportation before use, periodically, and when the shutdown time exceeds the specified time limit.
Article 54 An enterprise shall, in accordance with the relevant verification management system, form verification control documents, including verification schemes, reports, evaluations, deviation handling and preventive measures.
Article 55 The verification shall be carried out in accordance with the predetermined and approved scheme, the verification report shall be examined and approved, and the verification documents shall be filed.
Article 56 An enterprise shall use the relevant facilities and equipment correctly and reasonably according to the parameters and conditions determined through verification.

 

 

 

Section 7 Computer System
Article 57 An enterprise shall establish a computer system that can meet the requirements for the management and quality control of the whole business process, realize the traceability of drug quality, and meet the conditions for the implementation of electronic drug supervision.
Article 58 An enterprise computer system shall meet the following requirements:
（1） There are servers and terminals supporting the normal operation of the system;
（2） There is a secure and stable network environment, a fixed access to the Internet and a secure and reliable information platform;
（3） There is a LAN to realize information transmission and data sharing between departments and posts;
（4） It has the functions of generating, printing and managing bills for drug business;
（5） There are application software and relevant databases that meet the requirements of this specification and the actual needs of enterprise management.
Article 59 The entry, modification, preservation and other operations of all kinds of data shall comply with the requirements of the scope of authorization, operating procedures and management system, and ensure that the data is original, true, accurate, safe and traceable.
Article 60 During the operation of the computer system, data related to the operation and management of enterprises shall be stored in a safe and reliable manner and backed up on a daily basis. The backed up data shall be stored in a safe place, and the retention period of recorded data shall meet the requirements of Article 42 of these Standards.
Section VIII Procurement
Article 61 An enterprise's procurement activities shall meet the following requirements:
（1） Determine the legal qualification of the supplier;
（2） Determine the legitimacy of purchased drugs;
（3） Verify the legal qualification of the sales personnel of the supplier;
（4） Sign a quality assurance agreement with the supplier.
For the first enterprises and varieties involved in the procurement, the procurement department shall fill in relevant application forms, which shall be reviewed and approved by the quality management department and the enterprise's quality director. If necessary, field investigation shall be organized to evaluate the quality management system of the supplier.
Article 62 In the examination and verification of a first run enterprise, the following materials affixed with its original official seal shall be examined to confirm their authenticity and validity:
（1） A copy of the Pharmaceutical Production License or Pharmaceutical Trade License;
（2） Copy of business license and annual inspection certificate;
（3） A copy of the certificate of the GMP or the certificate of the GMP;
（4） The style of relevant seals and accompanying bills (invoices);
（5） Account name, bank and account number;
（6） Copies of Tax Registration Certificate and Organization Code Certificate.
Article 63 When purchasing the first marketed varieties, the legitimacy of the drugs shall be examined, and the copies of the drug production or import approval documents affixed with the original seal of the supplier shall be obtained and examined. Only those without errors after examination can be purchased.
The above materials shall be included in the drug quality archives.
Article 64 An enterprise shall verify and retain the following materials of the sales personnel of the supplier:
（1） A copy of the ID card of the salesperson affixed with the official seal of the supplier;
（2） Power of attorney stamped with the original seal of the supplier and the seal or signature of the legal representative, which shall indicate the name and ID card number of the authorized person, as well as the variety, region and duration of authorized sales;
（3） Data related to the supplier and the supply variety.
Article 65 The quality assurance agreement signed between the enterprise and the supplier shall at least include the following contents:
（1） Clarify the quality responsibilities of both parties;
（2） The supplier shall provide the required data and be responsible for its authenticity and effectiveness;
（3） The supplier shall issue invoices in accordance with national regulations;
（4） The drug quality meets the drug standards and other relevant requirements;
（5） The packaging, labels and instructions of drugs conform to relevant regulations;
（6） Quality assurance and responsibility of drug transportation;
（7） The validity period of the quality assurance agreement.
Article 66 When purchasing drugs, enterprises shall ask for invoices from suppliers. The invoice shall state the generic name, specification, unit, quantity, unit price, amount, etc. of the drug; If they cannot be listed in full, a List of Goods Sold or Taxable Services Provided shall be attached, and the original seal of the supplier's special seal for invoices shall be affixed, and the tax invoice number shall be indicated.
Article 67 The name, amount and product name of the purchasing and selling unit on the invoice shall be consistent with the flow of payment, amount and product name, and shall correspond to the content of the financial account. Invoices shall be kept according to relevant regulations.
Article 68 When purchasing drugs, purchasing records shall be established. The purchase record shall include the generic name, dosage form, specification, manufacturer, supplier, quantity, price, purchase date and other contents of the drugs. The place of origin shall also be indicated for the purchase of traditional Chinese medicine and prepared slices of traditional Chinese medicine.
Article 69 In the event of a disaster, epidemic situation, emergency, clinical emergency treatment or other special circumstances, as well as other circumstances in line with the relevant provisions of the State, the enterprise may purchase and sell drugs by direct transfer. The purchased drugs shall not be put into the warehouse of the enterprise, but directly sent from the supplier to the purchaser, and special purchase records shall be established to ensure effective quality tracking and traceability.
Article 70 The purchase of drugs under special control shall be carried out in strict accordance with the relevant provisions of the State.
Article 71 An enterprise shall regularly conduct a comprehensive quality review of the overall situation of drug procurement, establish drug quality reviews and quality archives of suppliers, and conduct dynamic tracking management.
Section IX Receiving and Acceptance
Article 72 The enterprise shall, in accordance with the prescribed procedures and requirements, receive and check the delivered drugs batch by batch to prevent unqualified drugs from entering the warehouse.
Article 73 Upon the arrival of drugs, the receiving personnel shall verify whether the mode of transportation meets the requirements, and check the drugs against the bills (invoices) and purchase records accompanying the drugs to ensure that the bills, accounts and goods are consistent.
The accompanying bill (invoice) shall include the common name, dosage form, specification, batch number, quantity, receiving unit, receiving address, delivery date and other contents of the supplier, manufacturer and drug, and shall be affixed with the original seal of the supplier's special seal for drug delivery.
Article 74 When refrigerated or frozen drugs arrive, they shall focus on the inspection and record of the mode of transportation, temperature records during transportation, transportation time and other quality control conditions. Those that do not meet the temperature requirements shall be rejected.
Article 75 The receiving personnel shall place the drugs that meet the receiving requirements in the corresponding areas to be inspected according to the requirements of variety and characteristics, or set up status signs to notify the acceptance. Refrigerated and frozen drugs shall be waiting for inspection in the cold storage.
Article 76 For drug acceptance, the inspection report of the same batch number shall be checked according to the batch number of the drug. If the supplier is a wholesale enterprise, the inspection report shall be affixed with its original seal for quality management. The transmission and preservation of the inspection report may take the form of electronic data, but its legitimacy and validity shall be guaranteed.

 

Article 77 The enterprise shall, in accordance with the provisions on acceptance inspection, conduct batch by batch sampling inspection of the drugs delivered each time, and the samples taken shall be representative.
（1） For drugs of the same batch number, at least one minimum package shall be checked. However, if the manufacturer has special quality control requirements or the opening of the minimum package may affect the drug quality, the minimum package may not be opened;
（2） In case of damage, pollution, liquid leakage, seal damage and other abnormal packaging, as well as bulk cargo and consolidation, unpacking inspection shall be carried out to the minimum package;
（3） API with complete outer package and seal and label, and biological products subject to batch issuance management may not be unpacked for inspection.
Article 78 The acceptance personnel shall inspect and check the appearance, packaging, labels, instructions and relevant supporting documents of the sampled drugs one by one; After the acceptance, the sampled intact samples shall be returned to the original packaging box, sealed and marked.
Article 79 Pharmaceuticals under special control shall be checked and accepted in special warehouses or areas according to relevant regulations.
Article 80 In the inspection and acceptance of drugs, the inspection and acceptance records shall be made, including the generic name, dosage form, specification, approval number, batch number, production date, validity period, manufacturer, supplier, quantity of arrival, date of arrival, qualified quantity, inspection and acceptance results, etc. The acceptance personnel shall sign their names and acceptance date on the acceptance record.
The acceptance records of Chinese medicinal materials shall include the name of the product, the place of origin, the supplier, the quantity of goods delivered, and the quantity that has passed the acceptance inspection. The acceptance record of prepared slices of traditional Chinese medicine shall include the product name, specification, batch number, place of origin, production date, manufacturer, supplier, quantity of goods delivered, quantity passing the acceptance inspection, etc. The approval number shall also be recorded for the prepared slices of traditional Chinese medicine under the approval number management.
In case of unqualified acceptance, the unqualified items and disposal measures shall also be indicated.
Article 81 For the drugs under electronic supervision, the enterprise shall scan the drug electronic supervision code according to the provisions, and upload the data to the system platform of China Drug Electronic Supervision Network in a timely manner.
Article 82 Where an enterprise fails to print or paste the Chinese drug electronic supervision code as required, or the printing of the supervision code does not meet the requirements of the regulations, it shall reject the application. If the regulatory code information is inconsistent with the drug packaging information, the supplier shall be consulted in a timely manner, and shall not enter the warehouse before being confirmed, and shall report to the local drug regulatory department when necessary.
Article 83 The enterprise shall establish inventory records, and the drugs that pass the acceptance inspection shall be put into storage and registered in a timely manner; The unqualified ones shall not be put into storage and shall be handled by the quality management department.
Article 84 Where an enterprise conducts direct drug transfer in accordance with Article 69 of this Code, it may entrust the purchaser to conduct drug acceptance. The purchaser shall check and accept the drugs, scan the drug electronic supervision code and upload the data in strict accordance with the requirements of this specification, and establish a special inspection and acceptance record for directly transferred drugs. On the day of acceptance, relevant information of acceptance records shall be transferred to the direct dispatching enterprise.
Section X Storage and Maintenance
Article 85 Enterprises shall store drugs reasonably according to their quality characteristics and meet the following requirements:
（1） The drugs shall be stored according to the temperature requirements indicated on the package. If no specific temperature is indicated on the package, the drugs shall be stored according to the storage requirements specified in the Pharmacopoeia of the People's Republic of China;
（2） The relative humidity of stored drugs is 35%~75%;
（3） The drugs stored in the manual warehouse shall be subject to color code management according to the quality status: the qualified drugs shall be green, the unqualified drugs shall be red, and the drugs to be determined shall be yellow;
（4） Measures such as keeping away from light, light, ventilation, moisture, insects and rats shall be taken when storing drugs as required;
（5） The handling and stacking of drugs shall be carried out in strict accordance with the requirements of the outer packaging label, and the stacking height shall meet the requirements of the packaging diagram to avoid damaging the drug packaging;
（6） The drugs shall be stacked according to the batch number. The drugs of different batch numbers shall not be stacked together. The stacking distance shall not be less than 5 cm. The distance between the drugs and the internal walls, roofs, temperature control equipment, pipelines and other facilities of the warehouse shall not be less than 30 cm. The distance between the drugs and the ground shall not be less than 10 cm;
（7） Drugs and non drugs, external drugs and other drugs shall be stored separately, and Chinese medicinal materials and prepared slices of Chinese medicine shall be stored in separate warehouses;
（8） Drugs under special control shall be stored in accordance with the relevant provisions of the State;
（9） The bulk drugs with their outer packages removed shall be stored in a centralized manner;
（10） The shelves, trays and other facilities and equipment for storing drugs shall be kept clean and free from damage and sundries;
（11） Personnel without approval shall not enter the storage and operation area, and personnel in the storage and operation area shall not have any behavior that affects the quality and safety of drugs;
（12） No articles irrelevant to storage management shall be stored in the drug storage area.
Article 86 Maintenance personnel shall maintain drugs according to warehouse conditions, external environment, drug quality characteristics, etc. The main contents are:
（1） Guide and urge the storage personnel to store and operate the drugs reasonably;
（2） Check and improve storage conditions, protective measures and sanitary environment;
（3） Effectively monitor and control the temperature and humidity of the warehouse;
（4） Inspect the appearance, packaging and other quality conditions of the drugs in stock according to the maintenance plan, and establish maintenance records; Special maintenance shall be carried out for varieties with special requirements for storage conditions or with short term of validity;
（5） The drugs found to have problems shall be locked and recorded in the computer system in a timely manner, and the quality management department shall be notified to deal with them;
（6） Chinese medicinal materials and prepared slices of Chinese medicine shall be maintained and recorded in an effective way according to their characteristics, and the maintenance methods adopted shall not cause pollution to the drugs;
（7） Regularly summarize and analyze maintenance information.
Article 87 An enterprise shall adopt a computer system to automatically track and control the expiration date of the drugs in stock, and take measures such as early warning of the expiration date and automatic locking when the expiration date is exceeded to prevent the sale of expired drugs.
Article 88 When a drug leaks liquid, gas or powder due to damage, safety measures should be taken quickly to prevent pollution to the storage environment and other drugs.
Article 89 Measures shall be taken immediately to stop the sale of drugs with doubtful quality, which shall be locked in the computer system and reported to the quality management department for confirmation. The following measures shall be taken for drugs with quality problems:
（1） It shall be stored in a special place with obvious signs and effectively isolated, and shall not be sold;
（2） If it is suspected that the drug is counterfeit, it shall be reported to the drug regulatory department in a timely manner;
（3） Drugs under special control shall be disposed of in accordance with the relevant provisions of the State;
（4） The handling process of unqualified drugs shall have complete procedures and records;
（5） Unqualified drugs shall be found out and analyzed, and preventive measures shall be taken in a timely manner.
Article 90 The enterprise shall regularly take stock of the drugs in stock to ensure that the accounts are consistent with the goods.

 

 

 

Section XI Sales
Article 91 An enterprise shall sell drugs to legitimate purchasers, and verify the certificates of the purchasers and the identity certificates of the purchasers and delivery personnel, so as to ensure that the flow of drug sales is true and legal.
Article 92 The enterprise shall strictly examine the scope of production, business or diagnosis and treatment of the purchaser, and sell drugs according to the corresponding scope.
Article 93 When selling drugs, enterprises shall truthfully draw up invoices to ensure that the invoices, accounts, goods and payments are consistent.
Article 94 Enterprises shall keep good records of drug sales. The sales record shall include the generic name, specification, dosage form, batch number, expiry date, manufacturer, purchaser, sales quantity, unit price, amount, sales date, etc. Where direct drug transfer is carried out in accordance with Article 69 of this Code, special sales records shall be established.
The sales records of Chinese medicinal materials shall include the product name, specification, place of origin, purchaser, sales quantity, unit price, amount, sales date, etc; The sales record of prepared slices of traditional Chinese medicine shall include product name, specification, batch number, origin, manufacturer, purchaser, sales quantity, unit price, amount, sales date, etc.
Article 95 The sale of drugs under special control and drugs with special requirements of the State shall be carried out in strict accordance with the relevant provisions of the State.
Section 12 Ex warehouse
Article 96 The ex warehouse shall be rechecked against the sales records. The following conditions shall not be taken out of the warehouse and reported to the quality management department for handling:
（1） The drug package is damaged, polluted, the seal is not firm, the pad is not solid, the seal is damaged, etc;
（2） Abnormal noise or liquid leakage in the package;
（3） The label falls off, the handwriting is unclear, or the content of the label is inconsistent with the actual object;
（4） The drug has expired;
（5） Drugs with other abnormal conditions.
Article 97 A record shall be established for the ex warehouse review of pharmaceuticals, including the purchaser, generic name, dosage form, specification, quantity, batch number, period of validity, manufacturer, ex warehouse date, quality status, reviewers, etc.
Article 98 The ex warehouse of drugs under special control shall be reviewed in accordance with the relevant provisions.
Article 99 Substitute packing boxes for drug LCL shipment shall have conspicuous LCL marks.
Article 100 When a drug is delivered out of the warehouse, a bill (invoice) with the original seal of the enterprise's special seal for drug delivery shall be attached.
If the enterprise transfers drugs directly according to Article 69 of this specification, the supplier shall issue two accompanying bills (invoices) to the direct transfer enterprise and the purchaser respectively when the direct transfer drugs leave the warehouse. The contents of the bill (invoice) accompanying the goods shall comply with the requirements of Paragraph 2 of Article 73 of these Specifications, and the name of the direct transfer enterprise shall also be indicated.
Article 101 Packing, loading and other operations of refrigerated and frozen drugs shall be carried out by specially assigned personnel and meet the following requirements:
（1） The on-board refrigerated box or insulated box shall meet the corresponding temperature requirements before use;
（2） The packing and sealing of refrigerated and frozen drugs shall be completed in a refrigerated environment;
（3） Before loading, the startup and operation status of refrigerated vehicles shall be checked, and the refrigerated vehicles can be loaded only after reaching the specified temperature;
（4） Transportation records shall be made at the time of departure, including the means of transportation and the time of departure.
Article 102 For the pharmaceuticals under electronic supervision, the codes shall be scanned and the data shall be uploaded at the time of ex warehouse.
Section XIII Transportation and Distribution
Article 103 The enterprise shall, in accordance with the requirements of the quality management system, strictly implement the operational procedures for transportation and take effective measures to ensure the quality and safety of drugs during transportation.
Article 104 Appropriate means of transport shall be selected according to the packaging and quality characteristics of the drugs and the conditions of the vehicles, roads, weather and other factors, and corresponding measures shall be taken to prevent damage, pollution and other problems.
Article 105 When shipping pharmaceuticals, the means of transport shall be inspected. If it is found that the conditions of transport do not meet the requirements, the pharmaceuticals shall not be shipped. During the transportation of drugs, the means of transport shall be kept closed.
Article 106 The enterprise shall handle, load and unload drugs in strict accordance with the requirements of the outer packaging label.
Article 107 An enterprise shall, in accordance with the requirements for temperature control of pharmaceuticals, take necessary measures for heat preservation, cold storage and freezing during transportation.
During transportation, drugs shall not be directly contacted with ice bags, ice floes and other refrigerants to prevent impact on drug quality.
Article 108 During the transportation of refrigerated or frozen drugs, the temperature data of refrigerated trucks, freezers or incubators shall be monitored and recorded in real time.
Article 109 An enterprise shall formulate an emergency plan for the transportation of refrigerated and frozen drugs, and be able to take corresponding measures to deal with equipment failures, abnormal weather effects, traffic congestion and other emergencies that may occur during transportation.
Article 110 Where an enterprise entrusts other units to transport drugs, it shall audit the quality assurance ability of the carrier to transport drugs, ask for relevant information about transport vehicles, and entrust only those that meet the conditions and requirements of transport facilities and equipment in this specification.
Article 111 When an enterprise entrusts the transportation of drugs, it shall sign a transportation agreement with the carrier, which shall specify the responsibility for drug quality, abide by the operational procedures for transportation and the time limit for in transit.
Article 112 An enterprise entrusting the transportation of drugs shall keep records to trace the quality of the transportation process. The record shall at least include the delivery time, delivery address, receiving unit, receiving address, bill number, number of drugs, mode of transportation, entrusted agent and carrier. If the vehicle is used for transportation, the license plate number shall also be indicated, and a copy of the driver's license shall be retained. Records shall be kept for at least 5 years.
Article 113 The loaded drugs shall be timely shipped and delivered as soon as possible. In the case of entrusted transportation, the enterprise shall require and supervise the carrier to strictly implement the entrusted transportation agreement, so as to prevent the quality of drugs from being affected due to too long in transit time.
Article 114 The enterprise shall take transportation safety management measures to prevent drug theft, robbery, loss, exchange and other accidents during transportation.
Article 115 The transportation of drugs under special control shall conform to the relevant provisions of the State.

 

 

 

Section XIV After sales Management
Article 116 The enterprise shall strengthen the management of the return of goods, ensure the quality and safety of drugs in the return process, and prevent the mixing of counterfeit drugs.
Article 117 An enterprise shall, in accordance with the requirements of the quality management system, formulate operational procedures for complaint management, which shall include complaint channels and methods, archival records, investigation and evaluation, handling measures, feedback and follow-up.
Article 118 An enterprise shall appoint full-time or part-time personnel to take charge of the management of after-sales complaints, find out the reasons for the quality problems complained about, take effective measures to deal with and feed back in a timely manner, and make records. When necessary, the supplier and the drug manufacturer shall be notified.
Article 119 An enterprise shall timely record the complaints and handling results in its archives for the convenience of inquiry and tracking.
Article 120 If an enterprise finds that the sold drugs have serious quality problems, it shall immediately notify the purchasing unit to stop selling, recover and make records, and report to the drug regulatory department at the same time.
Article 121 The enterprise shall assist the drug producing enterprise in fulfilling its recall obligations, convey and feed back the drug recall information in a timely manner according to the requirements of the recall plan, control and take back the drugs with potential safety hazards, and establish a drug recall record.
Article 122 The quality control department of an enterprise shall be staffed with full-time or part-time personnel to undertake the monitoring and reporting of adverse drug reactions in accordance with the relevant provisions of the State.

 

 

 

Section I Quality Management and Responsibilities
Article 123 The enterprise shall formulate quality management documents in accordance with relevant laws and regulations and the requirements of this Code, carry out quality management activities, and ensure the quality of drugs.
Article 124 An enterprise shall have the business conditions appropriate to its business scope and scale, including organizational structure, personnel, facilities and equipment, and quality management documents, and shall set up a computer system in accordance with regulations.
Article 125 The person in charge of an enterprise is the main person responsible for the quality of drugs, responsible for the daily management of the enterprise, responsible for providing the necessary conditions, ensuring that the quality management departments and quality management personnel effectively perform their duties, and ensuring that the enterprise distributes drugs in accordance with the requirements of this Code.
Article 126 An enterprise shall establish a quality management department or provide quality management personnel to perform the following duties:
（1） Supervise and urge relevant departments and personnel to implement the laws, regulations and this specification on drug management;
（2） Organize the preparation of quality management documents, and guide and supervise the implementation of documents;
（3） Review the qualification certificates of suppliers and their sales personnel;
（4） Be responsible for reviewing the legitimacy of the drugs purchased;
（5） Be responsible for the acceptance of drugs, guide and supervise the quality management of drug procurement, storage, display, sales and other links;
（6） Responsible for drug quality inquiry and quality information management;
（7） Be responsible for the investigation, handling and reporting of drug quality complaints and quality accidents;
（8） Be responsible for the confirmation and handling of unqualified drugs;
（9） Be responsible for the report of fake and substandard drugs;
（10） Responsible for reporting adverse drug reactions;
（11） Carry out drug quality management education and training;
（12） Be responsible for the review and control of computer system operation authority and the maintenance of basic data of quality management;
（13） Organize the calibration and verification of measuring instruments;
（14） To guide and supervise pharmaceutical services;
（15） Other duties that should be performed by the quality management department or quality management personnel.
Section II Personnel Management
Article 127 The personnel engaged in drug handling and quality management of the enterprise shall meet the qualification requirements specified in relevant laws and regulations and this Code, and shall not be prohibited from working by relevant laws and regulations.
Article 128 The legal representative or the person in charge of an enterprise shall have the qualification of a licensed pharmacist.
The enterprise shall, in accordance with the relevant provisions of the State, provide licensed pharmacists, be responsible for the examination and verification of prescriptions, and guide the rational use of drugs.
Article 129 The quality management, acceptance inspection and procurement personnel shall have the education background in pharmacy or medicine, biology, chemistry and other related majors, or have the professional and technical title in pharmacy. The personnel engaged in the quality management, acceptance inspection and procurement of Chinese herbal pieces shall have a secondary technical school degree or above in Chinese pharmacy or have a professional technical title at or above the junior level in Chinese pharmacy.
The salesperson shall have a high school education or above or meet the requirements specified by the provincial drug regulatory department. Dispensing personnel of prepared slices of traditional Chinese medicine shall have a technical secondary school degree or above in traditional Chinese medicine or have the qualification of traditional Chinese medicine dispensing personnel.
Article 130 All employees of the enterprise shall receive pre job training and continuing training on relevant laws and regulations as well as pharmaceutical professional knowledge and skills to meet the requirements of this specification.
Article 131 An enterprise shall, in accordance with the training management system, formulate an annual training plan and carry out training so that relevant personnel can correctly understand and perform their duties. The training work shall be recorded and archived.
Article 132 The enterprise shall provide conditions for the personnel who sell drugs under special management, drugs with special management requirements of the State, and refrigerated drugs to receive corresponding training, so that they can master relevant laws and regulations and professional knowledge.
Article 133 In the business premises, the staff of the enterprise shall wear clean and sanitary work clothes.
Article 134 The enterprise shall conduct pre post and annual health examination for personnel who have direct contact with drugs and establish health records. Those who suffer from infectious diseases or other diseases that may contaminate drugs may not engage in work that directly contacts drugs.
Article 135 In areas such as drug storage and display, no articles or personal articles irrelevant to business activities shall be stored, and no behavior affecting the quality and safety of drugs shall be allowed in the work area.
Section III Documents
Article 136 The enterprise shall, in accordance with the relevant laws and regulations and the provisions of this Code, formulate quality management documents that conform to the actual situation of the enterprise. The documents include the quality management system, job responsibilities, operating procedures, archives, records and vouchers, and the quality management documents are reviewed regularly and revised in a timely manner.
Article 137 The enterprise shall take measures to ensure that personnel at all posts correctly understand the contents of the quality management documents and ensure the effective implementation of the quality management documents.
Article 138 The quality control system for drug retail shall include the following:
（1） The management of drug purchase, acceptance, display, sales and other links shall also include the management of storage and maintenance if a warehouse is set up;
（2） Review of suppliers and purchased varieties;
（3） Management of prescription drug sales;
（4） Management of drug dismantling;
（5） The management of drugs under special control and drugs with special management requirements of the State;
（6） Management of records and vouchers;
（7） Management of collecting and querying quality information;
（8） Management of quality accidents and complaints;
（9） Management of examination, dispensing and verification of prescriptions of Chinese herbal medicines;
（10） Management of drug validity;
（11） Management of unqualified drugs and destruction of drugs;
（12） Provisions on environmental sanitation and personnel health;
（13） Management of pharmaceutical services such as providing medication consultation and guiding rational drug use;
（14） Regulations on personnel training and assessment;
（15） Provisions on adverse drug reaction reports;
（16） Management of computer system;
（17） Implement the provisions on electronic drug supervision;
（18） Other contents that should be specified.
Article 139 An enterprise shall specify the responsibilities of its responsible person, quality management, procurement, inspection and acceptance, salesperson, prescription verification, allocation and other posts, and the responsibilities of its storage, maintenance and other posts where a warehouse is set up.
Article 140 The responsibilities of quality management posts and prescription examination posts shall not be performed by other posts.
Article 141 The operating procedures for drug retail shall include:
（1） Drug procurement, acceptance and sales;
（2） Prescription review, allocation and verification;
（3） Prescription review, dispensing and verification of Chinese herbal medicines;

（4） Sales of drugs in parts;
（5） Sales of drugs under special control and drugs with special management requirements of the State;
（6） Display and inspection of drugs at the business premises;
（7） Storage of refrigerated drugs in business premises;
（8） Operation and management of computer system;
（9） The warehouse shall also include the operating procedures for storage and maintenance.
Article 142 An enterprise shall establish records related to the purchase, acceptance, sale, display inspection, temperature and humidity monitoring, and disposal of unqualified drugs, so as to be true, complete, accurate, effective, and traceable.
Article 143 Records and relevant vouchers shall be kept for at least 5 years. Records and vouchers of drugs under special management shall be kept according to relevant regulations.
Article 144 When recording data through the computer system, relevant personnel shall log in the computer system through authorization and password according to the operating procedures to enter data, so as to ensure that the data is original, true, accurate, safe and traceable.
Article 145 The data of electronic records shall be backed up regularly in a safe and reliable manner.
Section 4 Facilities and Equipment
Article 146 The business premises of an enterprise shall be suitable for its drug business scope and scale, and shall be separated from drug storage, office work, life support and other areas.
Article 147 The business premises shall have appropriate facilities or take other effective measures to avoid the influence of the outdoor environment on drugs, and shall be spacious, bright, tidy and sanitary.
Article 148 The business premises shall have the following business equipment:
（1） Racks and counters;
（2） Equipment for monitoring and regulating temperature;
（3） Those who deal in the preparation of Chinese herbal medicines shall have the equipment for storing the prepared slices and dispensing prescriptions;
（4） Those dealing in refrigerated drugs shall have special refrigerated equipment;
（5） Those who deal in Category II psychotropic drugs, toxic traditional Chinese medicine varieties and opium poppy shells shall have special storage equipment that complies with safety regulations;
（6） Dispensing tools and packaging supplies required for drug disassembly and sales.
Article 149 An enterprise shall establish a computer system that meets the requirements of business operation and quality management, and meet the conditions for the implementation of electronic drug supervision.
Article 150 Where an enterprise sets up a warehouse, it shall ensure that the internal wall and top of the warehouse are smooth and clean, the ground is flat, and the doors and windows are tightly structured; There are reliable safety protection, anti-theft and other measures.
Article 151 A warehouse shall have the following facilities and equipment:
（1） Equipment effectively isolated from the ground;
（2） Light proof, ventilated, moisture-proof, insect proof, rat proof and other equipment;
（3） Equipment for effective monitoring and control of temperature and humidity;
（4） Lighting equipment meeting the requirements of storage operation;
（5） Special place for acceptance;
（6） Special storage place for unqualified drugs;
（7） Those who deal in refrigerated drugs shall have special equipment suitable for their varieties and scale of operation.
Article 152 The handling of drugs under special control shall have storage facilities that meet the requirements of the State.
Article 153 Special warehouses shall be set up for the storage of prepared slices of traditional Chinese medicine.
Article 154 Enterprises shall, in accordance with the relevant provisions of the State, regularly calibrate or verify measuring instruments, temperature and humidity monitoring equipment, etc.

 

 

Section V Procurement and Acceptance
Article 155 When purchasing drugs, enterprises shall comply with the relevant provisions of Section 8, Chapter II of these Standards.
Article 156 Upon the arrival of drugs, the receiving personnel shall verify the actual drugs according to the purchase records against the bills (invoices) accompanying the goods of the supplier to ensure that the bills, accounts and goods are consistent.
Article 157 The enterprise shall check and accept the arrived drugs batch by batch according to the prescribed procedures and requirements, and make acceptance records in accordance with Article 80 of this Code.
The samples taken for acceptance shall be representative.
Article 158 When refrigerated drugs arrive, they shall be inspected in accordance with the provisions of Article 74 of these specifications.
Article 159 The drug inspection report shall be checked in accordance with the provisions of Article 76 of these specifications when checking drugs.
Article 160 Pharmaceuticals under special control shall be checked and accepted in accordance with relevant regulations.
Article 161 Pharmaceuticals that pass the acceptance inspection shall be put into storage or on the shelf in a timely manner. Pharmaceuticals under electronic supervision shall also be scanned and uploaded in accordance with the provisions of Article 81 and Article 82 of this Code. Those that fail the acceptance inspection shall not be put into storage or on the shelf, and shall be reported to the quality management personnel for handling.
Section 6 Display and Storage
Article 162 An enterprise shall monitor and regulate the temperature of its business premises so as to make the temperature of its business premises meet the requirements of normal temperature.
Article 163 Enterprises shall conduct regular sanitary inspections to keep the environment clean and tidy. The equipment for storing and displaying medicines shall be kept clean and sanitary, and no articles irrelevant to sales activities shall be placed, and measures such as pest and rat prevention shall be taken to prevent the pollution of medicines.
Article 164 The display of drugs shall meet the following requirements:
（1） Classify and display according to the dosage form, use and storage requirements, and set up eye-catching signs. The category labels are clear and placed accurately;
（2） The drugs shall be placed on the shelf (cabinet) in order to avoid direct sunlight;
（3） Prescription drugs and over-the-counter drugs are displayed in different areas, with special marks for prescription drugs and over-the-counter drugs;
（4） Prescription drugs shall not be displayed and sold by open shelf self selection;
（5） The external drugs shall be placed separately from other drugs;
（6） Drugs sold in parts shall be stored in the parts removal counter or special area;
（7） Category II psychotropic drugs, toxic traditional Chinese medicines and poppy shells shall not be displayed;
（8） The refrigerated drugs shall be placed in the refrigeration equipment, and the temperature shall be monitored and recorded as required to ensure that the storage temperature meets the requirements;
（9） The writing of the bucket chart of the Chinese herbal medicine cabinet shall be in the correct name and character; The bucket shall be rechecked before loading to prevent wrong bucket and cross bucket; The bucket shall be cleaned regularly to prevent insects, mildew and deterioration of the prepared slices; Clean and record the prepared slices of different batches before loading;
（10） Special areas shall be set up for dealing in non drugs, which shall be clearly separated from the drug areas, and shall have eye-catching signs.
Article 165 An enterprise shall regularly inspect the drugs displayed and stored, focusing on the drugs that are disassembled, the drugs that are easy to deteriorate, have a near expiry date, have been placed for a long time, and the prepared slices of traditional Chinese medicine. Drugs with quality problems shall be removed from the cabinet in a timely manner and the sales shall be stopped. The quality management personnel shall confirm and handle the drugs and keep relevant records.
Article 166 The enterprise shall track and manage the expiration date of drugs to prevent the expired use that may occur after the drugs with near expiration date are sold.
Article 167 Where an enterprise sets up a warehouse, the drug storage and maintenance management in the warehouse shall comply with the relevant provisions of Section 10 of Chapter II of these Regulations.
Section 7 Sales Management
Article 168 An enterprise shall hang its Pharmaceutical Trade License, business license, registration certificate of licensed pharmacist, etc. in a prominent position on its business premises.
Article 169 Business personnel shall wear work cards with photos, names, posts and other contents. If they are licensed pharmacists and pharmaceutical technicians, their work cards shall also indicate their practicing qualifications or pharmaceutical professional and technical titles. A licensed pharmacist who is on the job shall list his name clearly.
Article 170 The sale of drugs shall meet the following requirements:
（1） Prescriptions can be dispensed only after being reviewed by licensed pharmacists; The drugs listed in the prescription shall not be changed or substituted without authorization. Prescriptions with incompatibilities or overdoses shall be refused to be dispensed, but may be dispensed if they are corrected or re signed for confirmation by the prescribing physician; The prescription can be sold after being approved by the other party;
（2） The personnel who examine, distribute and check the prescription shall sign or seal the prescription, and keep the prescription or its copy in accordance with the relevant provisions;
（3） When selling drugs with near expiry date, the customer shall be informed of the expiry date;
（4） The sales of Chinese herbal pieces shall be measured accurately, and the decocting method and precautions shall be informed; The provision of the service of decocting prepared slices of traditional Chinese medicine shall comply with the relevant provisions of the State.
Article 171 When selling drugs, an enterprise shall issue a sales certificate, which shall include the name, manufacturer, quantity, price, batch number, specifications, etc. of the drugs, and keep a good sales record.
Article 172 The split sale of drugs shall meet the following requirements:
（1） The personnel in charge of the split sales have received special training;
（2） The dismantled workbenches and tools shall be kept clean and sanitary to prevent cross contamination;
（3） Keep records of the split sales, including the start date of the split, the generic name, specification, batch number, manufacturer, expiration date, sales quantity, sales date, split and reviewer of the drug;
（4） Clean and hygienic packaging shall be used for sales in parts, and the packaging shall indicate the name, specification, quantity, usage, dosage, batch number, expiry date, name of the pharmacy and other contents of the drug;
（5） Provide the original or copy of the drug manual;
（6） Keep the original packaging and instructions during the sales period.
Article 173 The sale of drugs under special control or drugs with special requirements of the State shall strictly comply with the relevant provisions of the State.
Article 174 Drug advertising and publicity shall strictly comply with the provisions of the State on advertising control.
Article 175 Personnel who are not employees of the enterprise shall not engage in drug sales related activities at the business premises.
Article 176 When selling a drug under electronic supervision, it shall scan the code and upload the data.
Section VIII After sales Management
Article 177 Except for quality reasons, once a drug has been sold, it may not be returned or replaced.
Article 178 An enterprise shall publish the supervision telephone number of the drug regulatory department at its business premises, set up a customer opinion book, and promptly handle customer complaints about drug quality.
Article 179 The enterprise shall collect and report the adverse drug reaction information in accordance with the provisions of the State on the adverse drug reaction reporting system.
Article 180 Where an enterprise discovers that the sold drugs have serious quality problems, it shall take timely measures to recover the drugs and make records, and report to the drug regulatory department at the same time.
Article 181 The enterprise shall assist the drug producing enterprise in fulfilling its recall obligations, control and recall the drugs with potential safety hazards, and establish a drug recall record.

 

 

 

Article 182 The management of the headquarters of drug retail chain enterprises shall comply with the relevant provisions of this Code for drug wholesale enterprises, and the management of stores shall comply with the relevant provisions of this Code for drug retail enterprises.
Article 183 These specifications are the basic requirements for the quality control of drug distribution. Specific requirements for enterprise information management, automatic monitoring of drug storage and transportation temperature and humidity, drug acceptance management, drug cold chain logistics management, retail chain management, etc. shall be separately formulated by the State Food and Drug Administration in the form of appendix.
Article 184 The meanings of the following terms in this Code are:
（1） On the job: the registered personnel who determine the labor relationship with the enterprise.
（2） On duty: relevant personnel perform their duties in the specified position during working hours.
（3） First run enterprises: pharmaceutical production or trading enterprises with which the supply and demand relationship occurs for the first time when purchasing pharmaceuticals.
（4） First sale varieties: drugs purchased by the enterprise for the first time.
（5） Original seal: the original seal of the enterprise, the special seal for invoice, the special seal for quality management, and the special seal for drug ex warehouse affixed on the relevant documents or vouchers to prove the identity of the enterprise in the purchase and sales activities. It cannot be the seal after printing, photocopying, or copying.
（6） To be inspected: it refers to the state of isolating or distinguishing the drugs arrived or returned after sales in an effective way and waiting for quality acceptance before warehousing.
（7） Spare goods: refer to medicines that have been disassembled for transportation and storage.
（8） LCL shipment: It refers to the method of assembling bulk drugs into the same packing box for shipment.
（9） Split Sales: the method of splitting the minimum package for sales.
（10） Drugs with special management requirements of the state: drugs with special regulatory measures implemented by the state for protein assimilation preparations, peptide hormones, compound preparations containing special drugs and other varieties.
Article 185 The quality management standards for drug procurement, storage and maintenance of medical institutions' pharmacies and family planning technical service institutions shall be separately formulated by the State Food and Drug Administration in consultation with relevant competent departments.
The regulations on quality control of drugs sold on the Internet shall be formulated separately by the State Food and Drug Administration.
Article 186 If a drug handling enterprise violates these Regulations, it shall be punished by the drug regulatory department in accordance with Article 79 of the Drug Administration Law of the People's Republic of China.
Article 187 This Code shall come into force as of June 1, 2013. In accordance with the provisions of Article 16 of the Drug Administration Law of the People's Republic of China, the specific implementation measures and steps shall be stipulated by the State Food and Drug Administration.