"Drug License Management Measures":
Chapter II applying for "Drug License" conditions
Article 5 The opening of drug retail enterprises, should be in line with the number of the local resident population, geographic area, traffic conditions and the actual needs of the requirements, in line with the principle of convenience to the public purchase of medicines, and in line with the following set of provisions:
(a) to have a guarantee that the (a) have rules and regulations to ensure the quality of the medicines they operate;
(b) have pharmacy technicians who are qualified according to law; pharmaceutical retail enterprises operating prescription drugs and Class A non-prescription drugs must be equipped with licensed pharmacists or other pharmacy technicians who are qualified according to law. The person in charge of quality should be more than one year (including one year) experience in quality management of drug business.
The operation of Class B non-prescription drug retail enterprises, as well as rural townships below the establishment of drug retail enterprises, should be in accordance with the "Drug Administration Law Enforcement Regulations," Article 15 of the provisions of the business staff, the conditions should be equipped with licensed pharmacists. Enterprise business hours, the above personnel should be on duty.
(C) the enterprise, the legal representative of the enterprise, the person in charge of the enterprise, the person in charge of quality without the "Drug Administration Law," Article 76, Article 83 of the circumstances;
(D) has with the drugs operated by the appropriate place of business, equipment, warehousing facilities, as well as the health environment. Where a retail pharmacy is set up within a supermarket or other commercial enterprise, it must have an independent area;
(v) have the ability to equip itself with the medicines needed to meet the needs of local consumers, and be able to guarantee a 24-hour supply. Drug retailers should have the number of varieties of essential medicines by the provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration in conjunction with the local situation to determine.
The state on the operation of narcotic drugs, psychotropic drugs, toxic drugs for medical use, preventive biological products otherwise provided, from its provisions.
"Interim Provisions on the Administration of the Circulation of Prescription Drugs and Non-prescription Drugs"
Chapter III Retail Pharmacies
Article IX sales of prescription drugs and non-prescription drugs of Class A retail pharmacies must have the "Drug Business Enterprise License".
Retail pharmacies selling prescription drugs and Class A non-prescription drugs must be equipped with a resident licensed pharmacist or pharmacist or more pharmacy technicians.
The "Drug Business Enterprise License" and the certificate of the licensed pharmacist should be hung in a conspicuous and easily visible place. Licensed pharmacists should wear a badge indicating their name, technical title and other content.
Code of Practice for the Quality Management of Pharmaceutical Business
Chapter III Quality Management of Pharmaceutical Retailing
Section 1: Management Responsibilities
Article 58 Pharmaceutical retailing and retailing chain enterprises shall engage in business activities in compliance with the legally approved modes of business operation and scope of business operation, and shall hang the pharmaceutical business enterprise license, business license, and practice license that matches the requirements of the practitioners in a conspicuous place in the business store. Practitioner requirements in line with the proof of practice.
Article 59 The main person in charge of the enterprise is responsible for the quality of the drugs operated by the enterprise.
Article 60 Enterprises shall set up quality hairpin organizations or full-time quality management personnel, specifically responsible for enterprise quality management.
Article 61 Enterprises should be in accordance with relevant state laws, regulations and the norms, and combined with the actual enterprise, the development of quality management system. Management system should be regularly checked and assessed, and establish records.
Section II: Personnel and Training
Article 62 The person in charge of quality of the enterprise shall have a technical title in pharmacy.
Article 63 The prescription reviewer in the retail of drugs should be a licensed pharmacist or have a pharmacist or above (including pharmacist and Chinese pharmacist) professional and technical titles.
Article 64 The quality management and drug inspection personnel of the enterprise shall have a degree in pharmacy or related professions, - or have a technical title in pharmacy.
Article 65 Enterprises engaged in quality management, inspection, acceptance, storage, maintenance, business and other personnel should be professional training. Qualified after examination and licensed to work. The state has employment access provisions of the post, the staff need to pass the vocational skills appraisal and obtain a professional qualification certificate before taking up their posts.
Article 66 Enterprises should be organized annually for direct contact with the personnel of the drug health checks, and establish health records. Found to suffer from mental illness, infectious diseases and other diseases that may contaminate the drugs, should be promptly transferred from their jobs.
Section III Facilities and Equipment
Article 67 The drug retail enterprises should have business premises and drug warehouses appropriate to the scale of operation, and the environment is clean and free of pollutants. The business premises, warehouses, office life and other areas of the enterprise should be separated.
Article 68 The business premises and drug warehouses of drug retail enterprises shall be equipped with the following equipment:
(a) equipment to facilitate the display of drugs.
(B) the special management of drug storage equipment.
(C) in line with the requirements of the characteristics of drugs at room temperature, cool and refrigerated storage equipment.
(D) the necessary drug testing, acceptance, maintenance equipment.
(E) test and adjust the temperature and humidity of the equipment.
(F) to maintain a certain distance between the drugs and the ground equipment.
(VII) drug dust, moisture, pollution and pest control, rodent, mold and other equipment.
(H) the business of Chinese medicine tablets required for the allocation of prescriptions and clinical prescription concoctions of equipment.
Article 69 The retail chain of pharmaceutical enterprises shall set up distribution centers compatible with the scale of operation, warehousing, acceptance, inspection, maintenance and other facilities required with the same size of the wholesale enterprises. Retail chain stores of drug display, storage and other unavailability requirements should be the same as retail enterprises.