Health, industry and commerce administration, quality and technology supervision and management departments in their respective areas of responsibility for the use of drugs and medical equipment related work. Article 5 The use of drugs and medical devices should have the following conditions:
(a) have the qualification of pharmacy technicians and medical equipment or related professional and technical personnel;
(b) with the use of drugs and medical devices compatible with the premises, equipment, storage facilities, sanitation environment;
(c) with the use of drugs and medical devices (C) with the use of drugs and medical equipment quality management organization or personnel;
(D) with the use of drugs and medical equipment to ensure the quality of regulations;
(E) direct contact with the drugs, single-use sterile medical devices should be qualified health checks;
(F) laws, regulations, rules and regulations stipulate other conditions. Article 6 The following behaviors are prohibited for the use of pharmaceutical and medical devices:
(1) Falsification of the procurement and acceptance records of pharmaceutical and medical devices;
(2) Operating or disguised operation of pharmaceutical and medical devices by mail, voluntary consultation, consultation, clinical trial, etc.
(3) Promoting pharmaceutical and medical devices by means of medical diagnosis;
(4) Other prohibited behaviors as stipulated by laws, regulations, and rules. (d) Other prohibited behaviors stipulated by laws, regulations and rules. Article 7 The use of drugs and medical devices should be used in accordance with the quality management standards for the use of drugs, medical devices, the use of drugs and medical devices quality management standards. Article 8 The use of drugs shall be from the "drug production license" or "drug business license" and "business license" of the drug production and business enterprises to purchase their production and operation of drugs within the scope of the license.
Medical devices should be used from the "medical device manufacturer license" or "medical device business license" and "business license" of medical equipment manufacturers, operators to purchase their production and operation of medical devices within the scope of the license (except for medical devices not applicable to the license management). Article IX of drugs and medical devices using units to purchase drugs, medical devices must be established and strictly enforce the purchase inspection and acceptance system, the purchase of drugs, medical devices should be batch by batch (pieces) acceptance, records, and establish relevant information files, check the sales staff legal qualifications, product certification and labeling.
The acceptance record of drugs according to the relevant provisions of the state. Medical device acceptance records include: the name of the manufacturer, product name, specifications (model), production batch number (factory number), expiration date, registration number, supply unit, purchase quantity, purchase price, purchase date, acceptance of personnel. Medical device acceptance records should be true and complete, save to more than 2 years after the expiration date. Article X of pharmaceutical and medical equipment use units to accept gifts, donations of drugs, medical equipment, should be used within 5 days before the report of the local food and drug supervision and management department, the food and drug supervision and management department should be received from the date of the report within 10 days of the inspection, issue a written response, except as otherwise provided by law. In the event of natural disasters, sudden public **** events and other special circumstances, in accordance with the provisions of the law. Article XI of the storage of drugs, medical devices shall comply with legal standards, categorized storage. Unqualified drugs, medical devices should be divided into specific areas of separate storage, labeling standards; storage of drugs, medical devices, warehouses or facilities should be in line with the light, ventilation, temperature and humidity detection and regulation, dust, moisture, pollution, insects, rodents and other conditions. Article XII of the drug user unit shall carry out regular inspection of the unit of drugs, make a good record of inspection; self-check found, identified by the test, the quality of the announcement of unqualified drugs should be sealed in a timely manner, and unqualified drug name, specifications, batch number, production unit, expiration date, quantity, value, etc., registered, approved by the unit, reported to the local food and drug supervision and management department for the record; drug user unit Sealed unqualified drugs shall not be disposed of without authorization, sealed drugs should be destroyed in accordance with the local food and drug supervision and management department notified the designated destruction, the local food and drug supervision and management department should be on-site supervision. Article XIII of the deployment of drugs should be strictly enforced operating procedures, shall not estimate the amount of drugs. Article XIV of the drugs should be dispensed in accordance with the provisions of the use of the name of the drug, specifications, usage, dosage, expiration date of the drug bag; the remainder of the drugs should be used in the original packaging and storage. Article XV of the drug user units, drug retailers decoction of Chinese medicine, shall not be prior batch decoction, blending, the name or code name of the adult medicine.