Health, market supervision and management departments shall, in accordance with their respective responsibilities, is responsible for the supervision and management of the use of drugs and medical devices related work. Article IV of the use of units should be in accordance with state regulations, the establishment of drugs, medical equipment procurement, acceptance, storage, maintenance, maintenance, deployment, use and other management systems, in accordance with the law to assume responsibility for the safety of drugs and medical equipment. Chapter II Procurement and Acceptance Article 5 The use of units should be from the drug market license holder or with drug production, business qualifications of enterprises to purchase drugs, but the purchase of Chinese herbal medicine is not implemented except for the approval of management.
Users shall purchase medical devices from legally qualified medical device registrants, filers, production and management enterprises. Article 6 The use of units should be designated departments or personnel unified procurement of drugs and medical devices, other departments or personnel shall not purchase on their own. Article 7 The procurement of drugs and medical devices by bidding and tendering, the user shall strictly implement the relevant provisions of the state and the province, and accept the supervision of the drug supervision department and other relevant departments. Article VIII of the use of units to purchase drugs, medical devices, shall check the following information:
(a) drug production or business license and business license, medical device production or business license, filing voucher and business license;
(b) medical device product registration or filing vouchers;
(c) drug approval certificate;
(d) drug test report, biological equipment, and other relevant departments to supervise. (D) drug test reports, biological products batch issue certificate of conformity, medical device certificate of conformity;
(E) drugs, medical devices, the original salesperson's authorization and proof of identity.
Users should request the information specified in the preceding paragraph and establish a procurement file. Information for copies, should be stamped with the seal of the supplying enterprise.
Encourage the use of advanced technology to establish procurement files. Article IX of drugs, medical devices, the use of units should verify and record the mode of transportation to meet the requirements, check the drugs, medical equipment and accompanying single, ticket is consistent.
Refrigerated, frozen medicines, medical devices arrived, the use of units should also verify and record the transportation time, the temperature of the transportation process records and other quality control status. Does not meet the temperature requirements, should be rejected. Article 10 The use of units purchasing drugs, medical devices, should establish and implement the purchase inspection and acceptance system. Drugs, medical devices acceptance records should be signed by the acceptance. Acceptance of unqualified drugs, medical equipment, shall be dealt with in accordance with the procurement contract and the relevant provisions of the state.
Using units to accept donations of medicines and medical equipment, emergency medicines transferred from other using units, as well as outside the physician to bring their own medical equipment, should be in accordance with the provisions of the preceding paragraph for acceptance and record.
Record matters and record-keeping period in accordance with relevant state regulations. Chapter III storage, care and maintenance of Article XI of the use of units of storage of drugs and medical equipment, facilities, conditions, should be in line with the relevant provisions of the state, and in line with the drugs, medical equipment packaging labeling storage requirements. Article XII of the use of storage units of drugs and medical devices to implement the classification of storage. Separate storage of drugs and non-drugs; traditional Chinese medicine tablets, proprietary Chinese medicines, chemical drugs are stored separately, categorized storage.
Expired, expired, eliminated and other unqualified drugs, medical devices should be placed in the unqualified library (area), shall not be mixed with qualified drugs, medical devices.
Using units built a pharmacy, should be in line with national and provincial standards for pharmacy management. Article XIII of the use of units shall develop and implement a regular inspection system, the storage of drugs and medical devices for inspection, care and maintenance, monitoring and recording of temperature and humidity in the storage area.
The inspection found expired, expired, mold, insect damage, breakage, elimination of drugs, and expired, breakage, failure, elimination of medical devices, the use of units should be immediately sealed, registered, and in accordance with relevant regulations, report, deal with. Chapter IV Dispatch and use of Article 14 The use of units should be approved in accordance with the law within the scope of the diagnosis and treatment subjects or services for the use of drugs and medical devices. Article XV of the use of units should be deployed in accordance with the prescription of drugs. Prescription review and deployment should be recognized by the qualification of the pharmacist or other pharmacy technicians responsible. Article XVI of the use of units in direct contact with drugs and medical devices, should be annual health checks. Suffer from infectious diseases or other diseases that may contaminate drugs, medical devices, shall not engage in direct contact with drugs, medical devices.