Notice on Issuing the Interim Regulations for Strengthening the Supervision and Management of Pharmaceutical Retail Enterprises in Hefei

　　Hefei Municipal Food and Drug Administration

　　Hefei Municipal HR and Social Security Bureau

　　Hefei Municipal Bureau of Commerce

　　Hefei Municipal Health and Family Planning Commission

　　Hefei Municipal Administration for Industry and Commerce

Hefei Food and Drug Administration Document No. 244[2017]

Notice on Issuing the Hefei Municipal Provisional Regulations on Strengthening the Supervision and Management of Pharmaceutical Retail Enterprises

Notification

　　To the food and drug administration, HR and social security bureau, bureau of commerce, health and family planning commission, and administration for industry and commerce of all counties (cities) and development zones:

　　The "Hefei Municipal Provisional Regulations on Strengthening the Supervision and Management of Pharmaceutical Retail Enterprises" have been reviewed and approved at the 94th executive meeting of the Hefei Municipal People's Government and registered by the Municipal Government's Legal Affairs Office (Registration No. HFGS-2017-111). These regulations are hereby issued for your implementation.

　　Hefei Municipal Food and Drug Administration, Hefei Municipal HR and Social Security Bureau

　　Hefei Municipal Bureau of Commerce, Hefei Municipal Health and Family Planning Commission

　　Hefei Municipal Administration for Industry and Commerce

　　September 12, 2017

Hefei Municipal Provisional Regulations on Strengthening the Supervision and Management of Pharmaceutical Retail Enterprises

　　In order to strengthen the supervision and management of pharmaceutical retail enterprises, ensure drug quality and public drug safety, and in accordance with the "Pharmaceutical Administration Law of the People's Republic of China," the "Implementation Regulations of the Pharmaceutical Administration Law of the People's Republic of China," the "Management Measures for Drug Business Licenses" (Order No. 6 of the State Food and Drug Administration), the "Good Supply Practice for Drug Operation" (Order No. 28 of the State Food and Drug Administration), and the Anhui Provincial Food and Drug Administration's "Notice on Issuing the Standards for On-site Acceptance of Licenses for Anhui Provincial Pharmaceutical Retail Chain Enterprises and Anhui Provincial Pharmaceutical Retail Enterprises" (Anhui Food and Drug Administration Order No. [2015]38), and other relevant regulations, and in combination with the actual situation in our city, these regulations are hereby formulated.

　　I. Scope of Application

　　These regulations apply to pharmaceutical retail enterprises within the administrative area of Hefei City. This includes pharmaceutical retail chain enterprise headquarters, pharmaceutical retail chain stores (hereinafter referred to as chain stores), and individual pharmacies.

　　II. Operating Principles

　　The establishment and operation of pharmaceutical retail enterprises should follow the principles of convenience for the masses, reasonable layout, quality assurance, and standardized order. Chain operations are encouraged; the introduction of advanced business models and modern management methods is encouraged; and the extension of pharmaceutical retail outlets to newly built urban areas and rural areas is encouraged.

　　III. Operating Conditions

　　(I) Pharmaceutical retail chain enterprises.

　　1. Applicants for pharmaceutical retail chain enterprises must apply based on having 10 or more retail pharmacies. For counties (cities), the county (city) administrative area is the unit, and for Hefei City, the urban area is the unit. The 10 pharmacies should be in the same administrative jurisdiction. The pharmaceutical retail chain enterprise and its stores should have the same legal representative.

　　2. The person in charge of the pharmaceutical retail chain enterprise should have a junior college degree or above or an intermediate or higher professional technical title and be familiar with national laws, regulations, rules, and knowledge of the drugs operated.

　　3. The quality manager of the pharmaceutical retail chain enterprise should have a bachelor's degree or above, a registered pharmacist qualification (and the work unit should be consistent with the work unit stated in their "Registered Pharmacist Certificate"), and more than 3 years of experience in drug business quality management; they should also have the ability to make correct judgments and ensure implementation in quality management work.

　　4. The pharmaceutical retail chain enterprise should establish a quality management organization. The head of the quality management organization should have a registered pharmacist qualification (and the work unit should be consistent with the work unit stated in their "Registered Pharmacist Certificate") and more than 3 years of experience in drug business quality management, and be able to independently resolve quality issues during operations.

　　5. Those engaged in quality management work should have a junior college education or higher in pharmacy or related fields such as medicine, biology, or chemistry, or have a junior or higher professional title in pharmacy. Those engaged in acceptance and maintenance work should have a senior secondary vocational school education or higher in pharmacy, medicine, biology, chemistry or related fields, or have a junior or higher professional title in pharmacy; those engaged in acceptance and maintenance of Chinese herbal medicines and Chinese patent medicines should have a senior secondary vocational school education or higher in Chinese Pharmacy, or have a middle-level or above professional technical title in Chinese pharmacy.

　　6. Personnel engaged in drug quality management and acceptance work must be in their posts and cannot take on other business work.

　　7. Personnel engaged in procurement work should have a senior secondary vocational school education or higher in pharmacy or medicine, biology, chemistry or related fields; personnel engaged in storage and other work should have a high school education or higher.

　　8. The pharmaceutical retail chain enterprise headquarters should have operating premises, office space, and ancillary facilities appropriate to its operating scale. According to the operating scale and drug storage conditions, a normal temperature warehouse, a cool warehouse, and a cold storage facility that meets the requirements of the "Good Supply Practice for Drug Operation" should be established, with a total area of no less than 500 square meters. Warehouses should be divided into designated areas for goods awaiting inspection, qualified products, shipping (distribution), unqualified products, and returned goods. Separate warehouses should be established for Chinese herbal medicines and Chinese patent medicines. Each of the above areas should be clearly marked and color-coded. Medicines and non-medicines, internal and external medicines should be stored separately.

　　9. The pharmaceutical retail chain enterprise headquarters should use enclosed cargo vehicles to transport drugs. For the operation of refrigerated and frozen drugs, appropriate refrigeration and freezing facilities and equipment should be provided according to the operating scale and variety, and refrigerated trucks, refrigerated containers or insulated boxes that meet the requirements of drug characteristics should also be provided.

　　10. According to the requirements of the "Good Supply Practice for Drug Operation," a temperature and humidity automatic monitoring system should be installed in the warehouses storing drugs and in the equipment transporting refrigerated and frozen drugs. The monitoring system should automatically monitor and record the temperature and humidity of drug storage and the temperature of refrigerated and frozen drug transportation in real time. Related functions comply with the requirements of Appendix 3 "Automatic Temperature and Humidity Monitoring" in the "Good Supply Practice for Drug Operation".

　　11. The pharmaceutical retail chain enterprise headquarters should have an independent computer management information system, a dedicated computer room, and a dedicated server (not a microcomputer) to support the normal operation of the system. The computer system should be networked with the stores. This system should be used to automatically associate and control the procurement, receipt, warehousing, in-warehouse maintenance, outbound verification, distribution, and store sales of drugs; the system should comply with the management requirements of the "Good Supply Practice for Drug Operation," and have the conditions for being supervised by local food and drug regulatory authorities and medical insurance management agencies. The retail chain enterprise should have one or more personnel proficient in computer operation and management to maintain the enterprise computer management system. Personnel in relevant positions can proficiently operate the computer management information system.

　　(II) Independent and chain pharmacies.

　　1. The legal representative or enterprise head of an independent or chain pharmacy must possess a practicing pharmacist qualification (and the work unit must be consistent with the practicing unit stated on their "Practicing Pharmacist Registration Certificate".

　　2. Independent and chain pharmacies should have a practicing pharmacist (and the work unit must be consistent with the practicing unit stated on their "Practicing Pharmacist Registration Certificate"), responsible for prescription review and guiding rational drug use. If the business scope includes traditional Chinese medicine decoction pieces, a practicing traditional Chinese medicine pharmacist should be equipped.

　　3. Personnel engaged in quality management, acceptance, and procurement should have a junior college or higher education in pharmacy, medicine, biology, chemistry, or other related majors, or have a professional technical title in pharmacy. Personnel engaged in quality management, acceptance, and procurement of traditional Chinese medicine decoction pieces should have a junior college or higher education in traditional Chinese medicine or have a junior or higher professional technical title in traditional Chinese medicine.

　　4. Sales staff should have a senior high school or higher education level or meet the conditions specified by the provincial drug supervision and administration department. Personnel dispensing traditional Chinese medicine decoction pieces should have a junior college or higher education in traditional Chinese medicine or have a traditional Chinese medicine dispenser qualification.

　　5. Independent and chain pharmacies should have business premises (referring to the operating premises for pharmaceuticals and medical devices, hereinafter the same) and warehouses (optional) commensurate with the scale of operations, and be equipped with equipment for monitoring and adjusting temperature and humidity. The business premises area (referring to the same plane, building area) should be no less than 100 square meters; the operating area of independent and chain pharmacies set up within supermarkets and other commercial enterprises should be no less than 80 square meters and be an independent area enclosed on three sides. For existing independent and chain pharmacies with changes in registered Address, the above area standards shall be followed.

　　6. Independent and chain pharmacies should be equipped with information management facilities and systems such as computers and pharmaceutical sales receipt printers, covering all aspects of enterprise pharmaceutical procurement, storage, and sales, meeting the management requirements of "Good Supply Practice for Pharmaceuticals," and having the conditions to accept supervision from local food and drug regulatory departments and medical insurance management institutions. Relevant personnel should be proficient in the use of computer management information systems.

　　(III) If independent and chain pharmacies set up warehouses, the following regulations should be followed:

　　1. The usable area shall not be less than 20 square meters, and it shall be in the same building as the business premises;

　　2. The interior walls and ceiling should be smooth, the floor level, and the doors and windows tightly sealed. Equipment for effective isolation of pharmaceuticals from the ground should be provided, with equipment for light protection, ventilation, moisture-proofing, insect-proofing, and rodent-proofing;

　　3. Equipment for monitoring and controlling temperature and humidity;

　　4. Lighting equipment that meets the requirements for storage operations;

　　5. Acceptance area;

　　6. Storage area for unqualified pharmaceuticals;

　　7. For those engaged in the business of refrigerated pharmaceuticals, equipment suitable for the variety and scale of their operations;

　　8. Traditional Chinese medicine decoction pieces should have a dedicated warehouse.

　　(IV) Personnel of pharmaceutical retail enterprises engaged in pharmaceutical operations and quality management work should meet the qualification requirements stipulated by laws, regulations, and "Good Supply Practice for Pharmaceuticals," and shall not have any circumstances prohibited from employment by relevant laws and regulations.

　　IV. Management Requirements

　　(I) Pharmaceutical retail enterprises should operate pharmaceuticals according to the operating methods and scope approved by the "Pharmaceutical Business License," and prominently display the "Pharmaceutical Business License," business license, and practicing (traditional Chinese medicine) pharmacist registration certificate in the business premises.

　　(II) When purchasing, accepting, storing, and selling pharmaceuticals, pharmaceutical retail enterprises must strictly abide by the provisions of the "Pharmaceutical Management Law of the People's Republic of China," "Implementation Regulations of the Pharmaceutical Management Law of the People's Republic of China," "Methods for Supervising and Managing the Circulation of Pharmaceuticals," "Good Supply Practice for Pharmaceuticals," etc., adhere to honesty and trustworthiness, operate in accordance with the law, and prohibit any false or deceptive acts.

　　(III) Pharmaceutical retail enterprises should develop quality management documents that meet the actual conditions of the enterprise, including quality management systems, job responsibilities, operating procedures, archives, records, and vouchers, and regularly review and promptly revise quality management documents.

　　(IV) Records and relevant vouchers of pharmaceutical retail enterprises should be kept for at least 5 years. Records and vouchers for special-controlled pharmaceuticals shall be kept in accordance with relevant regulations.

　　(V) Pharmaceutical retail enterprises must take appropriate measures such as refrigeration, frost prevention, cool storage, moisture-proofing, insect-proofing, and rodent-proofing to ensure pharmaceutical quality.

　　(VI) Pharmaceutical retail enterprises must implement the relevant regulations on the classification management of prescription drugs and non-prescription drugs. When the practicing pharmacist or other legally qualified pharmaceutical technician of pharmaceutical retail enterprises operating prescription drugs and Class A non-prescription drugs is not on duty, a sign should be posted to inform the public, and the sale of prescription drugs and Class A non-prescription drugs should be suspended.

　　(VII) Pharmaceutical retail enterprises shall not give away prescription drugs or Class A non-prescription drugs to the public in the form of bundling sales, buying drugs for free drugs, or buying goods for free drugs. When selling pharmaceuticals, sales vouchers stating the name of the supplier, pharmaceutical name, manufacturer, batch number, quantity, Price, etc. must be issued.

　　(VIII) Pharmaceutical retail enterprises that operate non-pharmaceutical products should set up a special area that is clearly separated from the pharmaceutical area and has clear markings.

　　(IX) Pharmaceutical retail enterprises are prohibited from selling narcotic drugs, radioactive drugs, Class I psychotropic drugs, abortion drugs, anabolic agents, peptide hormones (except insulin), drug-related easily controlled chemicals, vaccines, and other drugs prohibited by laws and regulations. Pharmaceutical retail enterprises shall not operate Class II psychotropic drugs without approval.

　　(X) Pharmaceutical retail enterprises shall not provide operating counters, stalls, or invoices to any units or individuals, and shall not lease or lend "Pharmaceutical Business Licenses" or provide conditions for others to operate pharmaceuticals.

　　(XI) Pharmaceutical retail chain enterprises and their branches should have unified enterprise logos, unified quality control, unified procurement and distribution, unified personnel management, unified financial management, and unified network computer management. Branches shall not purchase pharmaceuticals on their own.

　　(XII) For independent pharmacies and chain pharmacies without pharmaceutical warehouses, pharmaceuticals must be stored in accordance with regulations in counters, shelves, and refrigerators, and traditional Chinese medicine decoction pieces in storage bins. They shall not be stored in other areas or mixed with other items.

　　(XIII) Personnel in various positions of pharmaceutical retail enterprises should receive pre-employment training and continuing education on relevant laws, regulations, and pharmaceutical professional knowledge and skills.

　　(XIV) Personnel in pharmaceutical retail enterprises who directly contact pharmaceuticals should undergo pre-employment and annual health examinations and establish health records. Personnel with infectious diseases or other diseases that may contaminate pharmaceuticals shall not be arranged to work in positions that directly contact pharmaceuticals.

　　(15) Pharmaceutical retail enterprises should proactively collect adverse reaction information on the drugs they operate and promptly report it to the monitoring department. Concealment or omission of reports is prohibited.

　　(16) If a pharmaceutical retail enterprise changes its business scope, registered address, warehouse address (including increases or decreases in warehouse area), legal representative, person in charge, or person in charge of drug quality, etc., which are licensed matters, it shall apply to the food and drug regulatory department for a change registration of the "Drug Business License" 30 days before the change of the original licensed matters. No change to licensed matters is permitted without approval. For changes in the registered matters of a pharmaceutical retail enterprise, an application for a change registration of the "Drug Business License" should be submitted to the food and drug regulatory department within 30 days after the change of the registered matters.

　　(17) If a pharmaceutical retail enterprise decides to suspend operations on its own, it should submit a business suspension application to the local food and drug regulatory department 5 days prior to the suspension of operations, and submit the original and copy of the "Drug Business License". If it needs to resume operations, the "Drug Business License" will be returned after the enterprise submits a written application for resuming operations and passes the on-site inspection and acceptance by the food and drug regulatory department.

　　V. Legal Liability

　　(1) If an applicant for administrative license conceals relevant information or provides false materials for applying for administrative license, the application will not be accepted or the administrative license will not be granted, and a warning will be given, and the applicant will not be allowed to apply for the same administrative license again within one year.

　　(2) Pharmaceutical retail enterprises shall strictly implement the "Pharmaceutical Administration Law of the People's Republic of China" and other relevant laws and regulations, operate legally, operate in a standardized manner, and be honest and trustworthy. According to the circumstances of illegal and irregular acts, corresponding administrative penalties shall be imposed in accordance with the law. If a crime is constituted, the case shall be transferred to the judicial organs for handling in accordance with the law.

　　(3) For pharmaceutical retail enterprises that violate these provisions, the food and drug regulatory department, in addition to imposing penalties in accordance with the law, shall also make a record of it, which will serve as an important basis for evaluating credit rating.

　　VI. Effective Period

　　These provisions shall come into force on October 1, 2017, and shall be valid for two years.