Special management of narcotic drugs, psychotropic substances, toxic drugs for medical use, supervision and management of radioactive drugs, in accordance with relevant state regulations. Article III of the province, city, county (including county-level cities and districts, hereinafter the same) drug supervision and management department is responsible for the administrative region of the medical institutions of the supervision and management of the use of drugs and equipment. Article IV of the medical institutions should be set up with its size of the drug and device management organization, or designate qualified personnel responsible for the management of drug and device management, to ensure the safety of drug and device use, to prevent the occurrence of drug and device sudden group adverse events. Article V medical institutions in direct contact with drugs and sterile medical devices, should be annual health checks and establish health records. Personnel suffering from infectious diseases and other diseases that may contaminate drugs and sterile medical devices shall not be engaged in direct contact with drugs and sterile medical devices until they are cured or excluded from possible contamination. Article 6 medical institutions shall establish the following management system:
(1) the purchase and acceptance of medicines and devices;
(2) the review of the entry and exit of medicines and devices;
(3) the report on the quality of medicines and devices and the monitoring and reporting of adverse reactions (events);
(4) the dispensing of medicines and the review of the storage and maintenance of medicines;
(5) the expiration date of the medicines to monitor
(vi) Preparation, storage and use of preparations;
(vii) Use and maintenance of medical devices;
(viii) Implantable medical device quality tracking;
(ix) Destruction of single-use sterile medical devices after use.
Two or more (including this level) of medical institutions on the matters specified in the preceding paragraph should be implemented microcomputerized management. Article VII medical institutions must purchase drugs from enterprises with drug production or wholesale business license.
Rural clinics and health centers can purchase drugs from distribution centers with drug wholesale qualifications and their locally established distribution points; direct procurement is difficult, you can entrust the local township (township) health centers to purchase on behalf of.
The purchase of the township (town) health center shall sign a quality responsibility agreement with the commissioning party, and in accordance with the provisions of this approach to the procurement of medicines, shall not be transferred in any name to other units or individuals on behalf of the purchase of drugs. Article VIII of the medical institutions shall be its drug and equipment management agencies or designated personnel unified procurement, centralized management of drugs, and properly preserved to prove that the drug procurement information of the relevant vouchers, the establishment of drug procurement files.
Pharmaceutical procurement files should include the following information provided by the supplier:
(a) drug production or wholesale drug license and a copy of the business license;
(b) a copy of the certificate of quality management standard for the production or operation of pharmaceuticals;
(c) imported drugs or pharmaceutical products and imported drug test certificate and test report, imported drug approvals, etc. Report, imported drugs and other drug approval documents such as a copy of the approval documents;
(d) biological products test certificates copies;
(e) drug sales staff unit authorization or power of attorney and its identity.
Copies of the information specified in the preceding paragraph (a) to (d) shall be stamped with the seal of the unit providing them. Article IX of the medical institutions should be purchased according to the batch number of drugs, the implementation of the purchase of drugs batch by batch acceptance, in addition to checking the qualifications of the supplier and the relevant drug documents, but also should check the appearance of the drugs, packaging, labeling, instructions, etc., and fill in the true and complete record of acceptance of drugs.
The drug acceptance record should include the generic name of the drug, dosage form, specifications, batch number, date of manufacture, expiration date, manufacturer, supplier, purchase quantity, purchase price, date of purchase, acceptance of the conclusion, etc., and experience the acceptance of the signature.
The drug acceptance record retention time shall not be less than 3 years. Drugs are valid for more than 3 years, the drug acceptance record retention time for the expiration of 1 year after the expiration date of the drug. Article X medical institutions procurement of Chinese herbal medicines, each package should indicate the name, origin, date, supply unit, with the sign of quality; procurement of Chinese medicine, each package should be marked with the name, specifications, origin, manufacturer, product batch number, date of production, etc.; the procurement of the implementation of the approval of the management of Chinese herbal medicines, Chinese medicine, its packaging should also indicate the approval number.
The packaging of Chinese herbal medicines and traditional Chinese medicinal herbs does not comply with the provisions of the preceding paragraph, medical institutions shall not be procured. Article XI of the medical institutions on the storage and management of drugs, in accordance with the relevant provisions of the national "Drug Business Quality Management Code". Article XII of the medical institutions shall be approved in accordance with the law within the scope of the diagnosis and treatment subjects or service items to use drugs. Article XIII of the medical institutions shall strictly implement the drug expiration date monitoring and management system, and regularly carry out inventory of expired drugs. The expiration of the expiration date of the drugs, must immediately stop using, and in accordance with relevant regulations. Article XIV of the medical institutions must be based on the medical institution physician prescription to the patient deployment of drugs. May not operate or in the form of charity clinics, charity sales, consulting services, trial, exhibition, mail, gift and other ways to disguise the operation of drugs.