The State Food and Drug Administration of the United States is in charge of drug quality supervision and management of medical institutions nationwide, and local drug supervision and management departments at all levels are in charge of drug quality supervision and management of medical institutions within their respective administrative areas. Medical institutions should establish and improve the drug quality management system, improve the quality management system of drug procurement, acceptance, storage, maintenance, deployment and use, do a good job in quality tracking, and clarify the post responsibilities of staff in all aspects.
1, medical institutions should have special departments responsible for the daily management of drug quality; If there is no special department, a special person shall be appointed to be responsible for drug quality management.
2. A medical institution shall submit an annual self-inspection report on drug quality management to the local drug supervision and administration department, which shall include the following contents:
(a) the implementation of the drug quality management system;
(2) Changes in the establishment of medical institutions;
(three) accept the supervision and inspection of the drug supervision and administration department and the implementation of the rectification;
(4) Opinions and suggestions on drug supervision and administration departments.
3, medical institutions must purchase drugs from enterprises with pharmaceutical production and operation qualifications.
4. Drugs used by medical institutions shall be purchased by specialized departments in accordance with regulations, and other departments of medical institutions and medical personnel are prohibited from purchasing by themselves. Medical institutions urgently need to import a small amount of drugs in clinic, which shall be handled in accordance with the relevant provisions of the Drug Administration Law and its implementing regulations.
5. When purchasing drugs, medical institutions should ask for and keep the legal bills of suppliers, and establish purchasing records to ensure that the tickets, accounts and goods are consistent. Legal bills include tax stamps and detailed lists, which must include the supplier's name, drug name, manufacturer, batch number, quantity, price and other contents, and the retention period of bills shall not be less than 3 years.
6, medical institutions must establish and implement the procurement acceptance system, the purchase of drugs should be batch by batch acceptance, and establish a true and complete record of drug acceptance. Medical institutions shall also abide by the provisions of the preceding paragraph when accepting donated drugs and allocating emergency drugs from other medical institutions.
The role of the hospital:
Hospital refers to a medical institution that provides patients with necessary medical examination, treatment measures, nursing technology, consulting services, rehabilitation equipment, rescue and transportation services in accordance with laws, regulations and industry norms, with the main purpose of saving lives.
Legal basis:
Measures for the supervision and administration of drugs in medical institutions
Article 40 The pharmaceutical supervisory and administrative department shall strengthen the education, training and management of its own staff, and urge them to perform their duties correctly. Failing to perform the duties prescribed in these Measures or abusing their powers, neglecting their duties or engaging in malpractices for selfish ends, the directly responsible person in charge and other directly responsible personnel shall be given corresponding administrative sanctions according to law; Those suspected of committing a crime shall be transferred to judicial organs for handling.