New document from the National Medical Products Administration outlines another new chain-store landscape.

On August 19, the Comprehensive Department of the National Medical Products Administration publicly sought comments on the Draft Supplementary Guidelines for Pharmaceutical Retail Chains under the "Good Supply Practice for Pharmaceuticals," aiming to strengthen the management of chain drugstores.

Strictly staff licensed pharmacists

According to the draft for comments, there are clear requirements regarding staffing for pharmaceutical retail chain enterprises:

The company headquarters should have functions such as quality management, pharmaceutical procurement, financial management, education and training, and personnel management. The qualifications of the company headquarters' legal representative, enterprise leader, quality manager, head of the quality management department, and other quality management personnel must comply with the relevant requirements for pharmaceutical wholesale enterprises outlined in the "Standard."

Chain enterprises should, in accordance with the "Good Practices for Pharmaceutical Distribution," equip themselves with sufficient licensed pharmacists or other pharmaceutical technicians, and establish systems to ensure that these professionals remain on duty and fulfill their responsibilities in pharmaceutical quality management and pharmaceutical services.

The specific requirements for staffing are as follows:

The enterprise's quality manager should hold a bachelor's degree or higher, possess a practicing pharmacist qualification, and have at least 3 years of experience in pharmaceutical distribution quality management, demonstrating the ability to make accurate judgments and effectively ensure implementation in quality management tasks.

The head of the enterprise's quality management department must hold a practicing pharmacist qualification and have more than 3 years of experience in pharmaceutical distribution quality management, capable of independently resolving quality issues during the business operations.

The legal representative or the person in charge of the enterprise shall hold the qualification of a practicing pharmacist. Enterprises must, in accordance with relevant national regulations, assign practicing pharmacists who are responsible for reviewing prescriptions and providing guidance on the rational use of medications.

Strictly supervise the performance of practicing pharmacists

According to the draft opinion, there are clear requirements regarding practicing pharmacists being on duty and providing pharmaceutical services.

Licensed pharmacists or other pharmaceutical technicians should provide pharmacy services in accordance with the unified service standards established by the chain enterprise, ensuring that consumers use medications safely and appropriately.

The corporate headquarters should be responsible for overseeing the performance of licensed pharmacists at chain stores, ensuring that prescription drugs are not sold without a valid physician’s prescription, prescriptions are properly reviewed before dispensing, and no prescription drugs are sold while the pharmacist is absent from their designated post.

Appendix 7: Management of Pharmaceutical Retail Chains (Draft for Soliciting Opinions)

Article 1: The pharmaceutical retail chain enterprises (hereinafter referred to as "chain enterprises") shall conduct their pharmaceutical business activities in compliance with the requirements of the "Good Supply Practice for Pharmaceutical Products" (hereinafter referred to as "the Guidelines") and the relevant provisions outlined in this Appendix.

Article 2: A chain enterprise consists of a corporate headquarters, a distribution center (warehouse), and several pharmaceutical retail outlets—these three components form a complete, integrated whole.

Article 3: Chain enterprises shall, in accordance with the requirements of the "Guidelines," establish a quality management system under the unified leadership of their corporate headquarters. This system must cover all aspects, including the headquarters' administrative departments, enterprise logistics and distribution facilities, and every single chain store. The system should ensure the implementation of unified corporate branding, standardized management practices, a consistent computerized system, uniform staff training, integrated procurement and distribution processes, centralized invoice management, and harmonized pharmaceutical service protocols. In this way, chain stores will be effectively managed in their business operations, enabling scaled and group-based management and operations.

Article 4: The corporate headquarters shall be responsible for establishing organizational structures or positions that align with the actual operations, clearly defining their respective duties, authorities, and interrelationships. It must also develop quality management system documents, provide guidance and oversight on their implementation, and carry out activities such as quality planning, quality control, quality assurance, quality improvement, and quality risk management. Ultimately, the headquarters bears managerial responsibility for the operational practices and quality management of all chain stores.

Chain stores should ensure that personnel in all positions effectively implement the quality management documents issued by the company headquarters. The legal representative and enterprise head of the chain store shall bear full responsibility for the pharmaceutical business activities conducted at that store.

Article 5: The corporate headquarters serves as the core of the chain enterprise's operations and management, responsible for pharmaceutical procurement, distribution, and quality & safety control, as well as the unified management of chain stores. Meanwhile, the distribution center (warehouse) acts as the organization tasked with storing, transporting, and delivering pharmaceutical products for the chain enterprise, ensuring the quality of medicines throughout the entire process—from storage to transportation and delivery. Lastly, the chain stores function as the pharmaceutical sales outlets of the enterprise, handling daily retail sales and providing pharmacy services to guarantee high-quality drug sales and customer care at the point of consumption.

(1) The company headquarters should have functions such as quality management, pharmaceutical procurement, financial management, education and training, and personnel management. The qualifications of the legal representative, enterprise head, quality manager, head of the quality management department, and other quality management personnel at the company headquarters must comply with the relevant requirements for pharmaceutical wholesale enterprises outlined in the "Standard."

(2) The distribution center should be equipped with functions such as receiving, inspection, storage, maintenance, outbound verification, transportation, and delivery.

(III) Chain stores, in accordance with the systems and standardized requirements set by the corporate headquarters, are responsible for daily pharmaceutical retail operations and pharmacy services, among other tasks.

Article 6: The corporate headquarters shall comply with the regulatory requirements for pharmaceutical wholesale enterprises as outlined in the "Guidelines," establishing an independent quality management organization responsible for building and implementing the quality management system, ensuring continuous compliance across all chain stores, and setting up a drug traceability system to achieve full drug traceability. The quality management organization shall be tasked with formulating unified quality management system policies for the corporate headquarters, quality management practices for chain stores, and pharmaceutical service standards—and shall ensure their consistent and effective implementation.

Article 7: The corporate head of the enterprise headquarters is primarily responsible for the pharmaceutical quality of the chain enterprise and bears full responsibility for the company's daily operations.

Article 8: The quality manager of the enterprise headquarters shall be a senior executive, fully responsible for pharmaceutical quality management across the chain enterprise. This person will independently fulfill their duties and hold decision-making authority over pharmaceutical quality management within the company.

Article 9: Chain enterprises shall, in accordance with the "Guidelines," equip themselves with sufficient licensed pharmacists or other pharmaceutical technicians, and establish a system to ensure that these professionals remain on duty and fulfill their responsibilities in pharmaceutical quality management and pharmaceutical services.

Article 10: Chain enterprises shall establish corresponding organizational structures, define their respective duties and authorities, and clearly outline the responsibilities of each department and position, including:

(1) Responsibilities of departments including quality management, procurement, distribution center, store management, finance, and information management;

(2) Job responsibilities of enterprise leaders, quality managers, and heads of departments such as quality management, procurement, distribution center, store management, finance, and information management;

(3) Job responsibilities including quality management, procurement, receiving, inspection, storage, maintenance, outbound verification, transportation, store management, finance, information management, and pharmaceutical services;

(4) Other job responsibilities related to pharmaceutical operations.

Article 11: Chain enterprises shall establish regulations and operational procedures to ensure the proper fulfillment of quality management responsibilities and maintain the quality of the pharmaceutical products they handle. These documents should, at a minimum, include:

(1) Provisions for internal audits of the quality management system;

(2) Provisions regarding the right of quality veto;

(3) Management of quality management documents;

(4) Management of quality information;

(5) Verification of the legality of drug procurement (including the supplier unit, sales personnel from the supplier unit, and the drugs being purchased);

(6) Management of pharmaceutical procurement, receiving, inspection, storage, maintenance, sales, issue from warehouse, and transportation;

(7) Provisions regarding specially managed drugs and drugs subject to specific national regulatory requirements;

(8) Management of drug expiration dates;

(9) Management of substandard drugs and drug destruction;

(10) Management of pharmaceutical product returns;

(11) Management of drug recalls and cooperation with pharmaceutical recall efforts;

(12) Management of pharmaceutical dispensing in chain stores;

(13) Management of quality inquiries, quality incidents, and quality complaints;

(14) Regulations on the pharmacovigilance system and reporting of adverse drug reactions;

(15) Management of store quality inspection and assessment;

(16) Regulations on environmental hygiene and personnel health;

(17) Provisions regarding the education, training, and assessment of quality management and pharmaceutical services;

(18) Management of facility and equipment storage and maintenance;

(19) Management of facility and equipment validation and calibration;

(20) Management of records and vouchers;

(21) Management of computer systems;

(22) Regulations on pharmaceutical traceability;

(23) Financial Management System.

Article 12: Chain enterprises shall establish unified quality management systems and operational procedures for their chain stores, with the specific implementation entrusted to the individual stores. These primarily include:

(1) Quality responsibilities for business and management positions;

(2) Pharmaceutical receiving and inspection management;

(3) Pharmaceutical display and sales management;

(4) Pharmaceutical Dispensing Management;

(5) Prescription Drug Sales Management;

(6) Management of retail drug dispensing;

(7) Management of specially controlled drugs and drugs subject to specific national regulatory requirements;

(8) Record and voucher management;

(9) Management of drug recalls and cooperation with pharmaceutical recall efforts;

(10) Management of quality information collection and inquiries, quality incidents, and quality complaints;

(11) Management of review, dispensing, and verification of traditional Chinese medicine decoction prescriptions;

(12) Management of drug expiration dates;

(13) Management of handling nonconforming drugs;

(14) Regulations on environmental hygiene and public health;

(15) Management of pharmaceutical services such as medication counseling and guidance on rational drug use;

(16) Regulations on Personnel Training and Assessment;

(17) Regulations on pharmacovigilance management and reporting of adverse drug reactions;

(18) Computer System Administration;

(19) Regulations on pharmaceutical traceability;

(20) Prescription Review and Responsible Management by Practicing Pharmacists;

(21) Attendance regulations for practicing pharmacists and other pharmaceutical technicians, as well as other matters that should be specified.

Article 13: The corporate headquarters shall develop an annual training plan that includes the affiliated chain stores, standardize the training content, and carry out training activities as required, while also establishing comprehensive training records.

Article 14: The corporate headquarters shall establish an annual health examination plan that includes all affiliated chain stores, take responsibility for ensuring that employees directly handling pharmaceutical products undergo pre-employment and annual health checks, and maintain comprehensive health records.

Article 15: Chain enterprises shall establish a quality management system and a computerized management system that meet the requirements of the "Standard" and its appendices, ensuring they cover pharmaceutical operations and quality traceability across the enterprise headquarters, distribution centers (warehouses), and chain stores. These systems must enable real-time control and comprehensive recording of every stage of pharmaceutical operations as well as the entire quality management process, thereby guaranteeing full traceability throughout the drug distribution lifecycle. Moreover, seamless real-time information transmission and data sharing via computer networks must be achieved among the enterprise headquarters, distribution centers (warehouses), and chain stores, supported by robust equipment and facilities designed to safeguard data security, along with contingency measures in place. In addition to complying with the requirements outlined in the "Standard," the computerized system must also satisfy the following criteria:

(1) The system enables information transmission, data sharing, and voucher management between the corporate headquarters and chain stores, with bidirectional, automatic, and real-time data transfer.

(II) The system shall not support chain-store branches in independently procuring pharmaceuticals;

(III) The system shall not allow chain stores to independently override quality control and drug-locking instructions issued by the headquarters;

(4) The information display system among chain stores allows only queries, and business transactions between chain stores are limited to transfer operations approved by the corporate headquarters.

Article 16: The quality management department of the enterprise headquarters is responsible for reviewing and controlling computer system operation permissions, as well as establishing, maintaining, and updating the foundational database for quality management.

(1) The quality management foundational database includes information such as supplier and product qualification details, qualifications of suppliers' sales personnel, chain store qualifications, and the business scope of chain stores.

(II) Basic quality management data are linked to the legality and effectiveness of corresponding chain stores and distributed pharmaceutical products, aligning with the business scope of each chain store. These data are automatically tracked, identified, and controlled by the system.

(III) Each chain store uses the quality management foundational database, which is uniformly maintained by the headquarters.

Article 17: The company headquarters shall review the legal qualifications of purchased pharmaceuticals, as well as those of suppliers and their sales personnel, and centrally manage the procurement of pharmaceutical products.

Article 18: Chain stores submit their procurement plans to the corporate headquarters via the computer system based on operational needs. After the headquarters reviews the store’s procurement plan, it will distribute the medicines according to the corresponding scope of business. Alternatively, the corporate headquarters may also directly deliver medicines to the stores, based on the stores’ medicine inventory levels and sales performance recorded in the computer system.

Chain-store outlets are prohibited from independently purchasing pharmaceutical products from other drug distributors, as well as from marketing authorization holders and traditional Chinese medicine decoction piece manufacturers.

Article 19: The distribution center (warehouse) shall be equipped with storage and transportation facilities and equipment that are suitable for its pharmaceutical business scope and scale, and that meet the quality characteristics of the medicines handled. This includes corresponding warehouse facilities (for temperature-sensitive or specially low-temperature products—particularly those requiring refrigeration or freezing—sufficiently sized cool rooms, cold storage facilities, refrigerated containers, insulated boxes, and refrigerated vehicles must be provided). Additionally, the facility must have a computerized warehouse management system and an automated temperature and humidity monitoring system. It should also possess functions such as receiving and inspection, storage and maintenance, outbound processing, transportation, and delivery, all while ensuring the quality and safety of the pharmaceutical products.

Article 20: Medicines operated by chain stores shall be uniformly distributed by the headquarters of the affiliated enterprise, and the distribution process must comply with the relevant requirements outlined in the "Standard." Chain stores are not permitted to accept any other medicines outside those distributed by their affiliated enterprise headquarters.

Article 21: When chain stores receive pharmaceutical products directly delivered by the corporate headquarters, they may simplify the receiving and inspection procedures, provided that the quality of the drugs is fully assured. Receiving and inspection personnel shall examine the transportation vehicles and conditions, verify the items against the computerized system's purchase plan and the accompanying delivery note from the headquarters, and cross-check the physical drugs for their generic name, specification, batch number, expiration date, manufacturer, marketing authorization holder, approval registration number, arrival date, quantity received, and integrity of the outer packaging. For refrigerated or frozen medications, the in-transit temperature must also be inspected. Once the quality status of the drugs has been confirmed, it should be verified and recorded in the computerized system, automatically generating a corresponding acceptance record.

Article 22: If the purchase plan, delivery documents, and actual goods do not match, the quality management personnel at the chain store shall contact the relevant departments at the company headquarters for resolution. Goods must not be accepted without prior confirmation.

Article 23: The corporate headquarters shall establish a pharmaceutical dispensing management system for chain stores and, through the computer system, monitor the specific sales performance of each store. This will enable controlled management of pharmaceutical transfers among chain locations, with real-time adjustments made in the computer system to reflect the redistribution of dispensed medications across stores, ensuring effective tracking of the accurate flow of these products.

(1) The transfer of medications between chain stores must be reported to and approved by the company headquarters; no store may independently reallocate drugs without prior authorization.

(2) Chain-store outlets submit to the company headquarters, via a computer system, data information including the names, specifications, quantities, dosage forms, marketing authorization holders, and manufacturing companies of the medicines requiring reallocation.

(3) The corporate headquarters shall issue dispensing documents for the medications requested by chain-store pharmacies through the computer system.

(4) The corporate headquarters shall designate dedicated personnel (who have undergone training before taking up their posts) to handle the allocation and distribution of pharmaceuticals among chain stores.

(5) Medicines transferred between chain stores shall be received and inspected for quality by the receiving party's inspection personnel, who must also maintain proper acceptance records in accordance with relevant pharmaceutical inspection regulations and ensure their safekeeping.

(6) Refrigerated medications, specially managed drugs, and medicines subject to specific national regulatory requirements cannot be directly exchanged between stores; instead, they must follow the return and distribution procedures.

Article 24: If a chain enterprise needs to outsource storage and distribution, it may entrust the storage and distribution of all pharmaceutical products within its business scope to an enterprise that meets the corresponding qualifications for pharmaceutical distribution.

(1) Before a chain enterprise commences entrusted storage and distribution services, it shall review the storage, transportation, and distribution capabilities as well as the quality assurance measures of the prospective entrusted enterprise. Upon passing the review, a quality assurance agreement or contract should be signed with the enterprise, clearly defining the quality responsibilities of both parties along with their respective rights and obligations, thereby ensuring the quality and safety of pharmaceuticals throughout the entire entrusted distribution process.

(2) The entrusted enterprise shall comply with the relevant provisions of the "Guidelines" and possess modern pharmaceutical logistics capabilities, with its storage and distribution capacity aligned with the scope of pharmaceutical products handled by the chain enterprise.

(3) Any quality issues arising during pharmaceutical distribution shall be handled according to the rights and obligations stipulated in the quality agreement, with both the commissioning and entrusted parties bearing their respective responsibilities.

(4) The enterprise headquarters' computer system should be effectively integrated with the trustee's computer system, enabling real-time data sharing. This integration will allow the enterprise headquarters to maintain real-time control over the entrusted pharmaceutical distribution process and record relevant data. Furthermore, pharmaceutical distribution information must be transmitted from the enterprise headquarters to the chain stores.

(5) Chain-store locations shall fulfill the responsibilities of receiving and inspecting goods, maintain accurate records, and promptly transmit the results back to corporate headquarters via the computerized management system.

Article 25: The corporate headquarters shall include the entrusted distribution enterprises within the scope of the chain enterprise's quality management system and establish a regular supervision and audit mechanism.

Article 26: The quality management department of the corporate headquarters shall analyze the collected laws, regulations, quality information, pharmacovigilance data, and other relevant information, then issue processed opinions to the chain stores. These opinions will guide and supervise each chain store in implementing the directives from the corporate headquarters, while also ensuring compliance checks are conducted on the execution process. Furthermore, the department will organize the chain stores to carry out legal requirements, regulatory guidelines, and quality management standards in full accordance with the law.

Article 27: The quality management department of the corporate headquarters shall regularly inspect and evaluate the implementation of quality management systems in chain stores, conducting a comprehensive inspection at least once per year. For any non-conformities identified during these inspections, corrective action recommendations must be issued, and the chain stores' progress in addressing these issues should be closely monitored.

Article 28: Chain-store outlets must immediately remove from shelves and lock in the computer system any pharmaceutical products suspected of quality issues. Products confirmed by the store’s quality management personnel as substandard—or those whose safety and quality cannot be verified—must not be sold. Suspicious-quality medications should be stored in a designated area, effectively segregated from other drugs, and promptly reported to the company headquarters.

The company headquarters is responsible for implementing unified management of the handling of non-compliant and quality-questionable pharmaceutical products.

Article 29: The corporate headquarters shall establish unified elements such as the company culture, business philosophy, product system branding, uniforms, and employee badges, and shall oversee their implementation across all affiliated chain stores.

Article 30: The corporate headquarters shall standardize the format of sales vouchers for chain stores. When chain stores sell pharmaceutical products, they must generate sales receipts automatically via a computer system, clearly indicating the name of each individual chain store.

Article 31: When chain enterprises sell pharmaceuticals through "online order, in-store delivery" or "online order, in-store pickup" methods, the corporate headquarters shall establish corresponding quality management systems and operational procedures, and oversee their implementation at chain stores. This ensures that, under the unified management of the corporate headquarters, each chain store maintains rigorous control over the quality and safety of pharmaceuticals throughout the entire sales and distribution process, while also guaranteeing that licensed pharmacists or other pharmacy professionals effectively provide pharmaceutical services.

Article 32: During the suspension of operations due to violations of the "Guidelines" or other relevant regulations by the enterprise headquarters, each affiliated chain store may continue selling qualified pharmaceutical products that have already been accepted and transferred to their stores, provided such products remain within their expiration dates.

Before the company headquarters resumes operations, none of its affiliated chain stores shall conduct medicine exchange activities among themselves, nor shall they obtain medicines from any other organizations or individuals.

Article 33: Chain enterprises shall, in accordance with the "Guidelines" and relevant appendices, establish unified pharmaceutical service standards at the corporate headquarters and provide standardized training and pharmaceutical service management for all staff members. Each chain store must implement these uniform pharmaceutical service standards to ensure public medication safety.

Article 34: When reviewing prescriptions, practicing pharmacists shall ensure that the prescriptions comply with the "Guidelines" and relevant national regulations, and shall take responsibility for the quality of prescription review. Pharmacists or other pharmaceutical technicians working in chain-store branches shall fulfill their responsibilities for dispensing and verifying prescriptions. After completing the prescription review, dispensing, and verification processes, practicing pharmacists and other pharmaceutical technicians must sign to confirm their actions; these signatures must be filed with and archived by the company headquarters for future reference.

Licensed pharmacists or other pharmaceutical technicians should provide pharmacy services in accordance with the unified service standards established by the chain enterprise, ensuring that consumers use medications safely and appropriately.

Article 35: The corporate headquarters shall be responsible for overseeing the performance of licensed pharmacists at chain stores, ensuring that no prescription drugs are sold without a valid physician’s prescription, that prescriptions are properly reviewed before dispensing, and that prescription drugs are not sold while the pharmacist is absent from their designated post.