Article 2 These Measures shall apply to the supervision and management of drug quality of medical institutions in People's Republic of China (PRC), and medical institutions shall abide by these Measures in purchasing, storing, dispensing and using drugs.
Article 3 The State Food and Drug Administration of the United States is in charge of the drug quality supervision and administration of medical institutions nationwide, and the local drug supervision and administration departments at all levels are in charge of the drug quality supervision and administration of medical institutions within their respective administrative areas.
Article 4 Medical institutions shall 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 links.
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.
Article 5 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.
The self-inspection report shall be submitted before 65438+February 3 1 this year. Article 6 Medical institutions must purchase drugs from enterprises with pharmaceutical production and marketing qualifications.
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.
Article 7 When purchasing drugs, medical institutions shall examine the supplier's Pharmaceutical Production License or Pharmaceutical Business License, business license, approval documents of drugs sold and other related documents, and verify the original power of attorney and ID card held by sales personnel.
The medical institution shall properly keep the copies of the above-mentioned certification documents stamped with the original seal of the supplier on the drugs purchased for the first time, and the retention period shall not be less than 5 years.
Article 8 When purchasing drugs, medical institutions shall 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.
Article 9 Medical institutions must establish and implement a procurement acceptance system, and the purchased drugs should be accepted batch by batch, and a true and complete drug acceptance record should be established.
Medical institutions shall also abide by the provisions of the preceding paragraph when accepting donated drugs and allocating emergency drugs from other medical institutions.
Article 10 The drug acceptance record shall include the generic name, manufacturer, specification, dosage form, batch number, production date, validity period, approval number, supplier, quantity, price, purchase date, acceptance date and acceptance conclusion.
Acceptance records must be kept for more than 1 year, but not less than 3 years.
Eleventh medical institutions should establish and improve the procurement system of Chinese herbal pieces, and purchase Chinese herbal pieces in accordance with the relevant provisions of the state.
Twelfth medical institutions should have special drug storage places, facilities and equipment. The storage of drugs shall meet the conditions indicated in the drug instructions.
Medical institutions need to temporarily store drugs in emergency rooms, ward nurse stations and other places, and should be equipped with counters that meet the conditions for drug storage. If there are special storage requirements, corresponding equipment shall be provided.
Article 13 When storing drugs, medical institutions should store them in different warehouses, zones and stacks according to the attributes and categories of drugs, and implement color-coded management. Drugs and non-drugs are stored separately; Chinese herbal pieces, Chinese patent medicines and chemicals are stored separately and classified; Expired, deteriorated, polluted and other drugs should be put into the unqualified library (area).
Article 14 Medical institutions shall formulate and implement a management system for drug storage and custody, and take necessary measures such as temperature control, moisture prevention, light protection, ventilation, fire prevention, insect prevention, rodent prevention and pollution prevention to ensure the quality of drugs.
Fifteenth medical institutions should be equipped with drug maintenance personnel, regularly check and maintain the stored drugs, monitor and record the temperature and humidity of storage areas, maintain storage facilities and equipment, and establish corresponding maintenance files.
Article 16 A medical institution shall establish a drug expiration date management system. Drug distribution should follow the principle of "first out in the near future".
Article 17 Narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs shall be stored in strict accordance with the provisions of relevant administrative regulations, and corresponding safety measures shall be taken. Eighteenth medical institutions should be equipped with pharmaceutical technicians who are suitable for the preparation and use of drugs and have passed the examination according to law, and are responsible for the examination and preparation of prescriptions.
Article 19 The tools, facilities, packages and areas used by medical institutions to prepare drugs shall meet the hygiene requirements and the corresponding preparation requirements.
Article 20 Medical institutions shall establish a management system for disassembling and dispensing drugs with minimum packaging to ensure the traceability of drug quality.
Twenty-first preparations prepared by medical institutions can only be used by their own units. Without the approval of the pharmaceutical supervisory and administrative department at or above the provincial level, medical institutions shall not use preparations prepared by other medical institutions, nor shall they provide preparations prepared by their own units to other medical institutions.
Twenty-second medical institutions should strengthen the quality control of drugs used. If counterfeit or inferior drugs are found, they should immediately stop using them, seal them up on the spot, keep them properly, and report to the local drug supervision and administration department in time. Before the drug supervision and administration department makes a decision, medical institutions shall not deal with it without authorization.
When a medical institution discovers a potential safety hazard of a drug, it shall immediately stop using it, notify the drug manufacturer or supplier, and report to the local drug supervision and administration department in time. If it is necessary to recall, the medical institution shall assist the pharmaceutical production enterprise to fulfill the obligation of drug recall.
Twenty-third medical institutions shall not directly sell prescription drugs to the public by mail, internet transactions, counter opening, and self-selection.
Article 24 Medical institutions shall gradually establish an electronic management system covering the whole process of quality control of drug purchase, storage, deployment and use, so as to realize the traceability of drug source and drug destination, and connect with the national drug electronic supervision system.
Twenty-fifth medical institutions should organize the personnel who have direct contact with drugs to have health check-ups every year and establish health records. Persons suffering from infectious diseases or other diseases that may contaminate drugs shall not engage in direct contact with drugs.
Twenty-sixth medical institutions should regularly organize personnel engaged in drug procurement, storage, maintenance, acceptance, deployment and use to participate in the training of pharmaceutical laws and regulations and pharmaceutical professional knowledge, and establish training files. Twenty-seventh pharmaceutical supervisory and administrative departments shall supervise and inspect the quality of drug procurement, storage, deployment and use in medical institutions, and establish supervision and inspection files of medical institutions.
The supervision and inspection situation and treatment results shall be recorded in writing, signed by the supervision and inspection personnel, and fed back to the inspected unit. If the problems found in the inspection need to be handled by other departments, they shall be transferred in time.
Article 28 Medical institutions shall actively cooperate with pharmaceutical supervisory and administrative departments to supervise and inspect the quality of drug procurement, storage, deployment and use according to law, and truthfully provide articles and records, vouchers, medical documents and other materials related to the items to be inspected, and shall not refuse or conceal them.
Twenty-ninth pharmaceutical supervisory and administrative departments should strengthen the supervision and sampling inspection of drugs in medical institutions.
The national or provincial drug supervision and administration department shall issue announcements regularly to announce the results of spot checks on drug quality in medical institutions.
If there is any objection to the quality sampling results, the reinspection procedures shall be implemented in accordance with relevant regulations.
Thirtieth pharmaceutical supervisory and administrative departments shall, according to the actual situation, establish credit files for drug quality management in medical institutions, and record the results of daily supervision and inspection, the investigation and punishment of illegal acts, etc.
Thirty-first pharmaceutical supervisory and administrative departments shall promptly accept, verify, reply and deal with the consultation, complaint and report of medical institutions on drug quality; If it does not belong to the responsibilities of this department, it shall be informed in writing and handed over to relevant departments for handling.
Article 32 The pharmaceutical supervisory and administrative department may, according to the annual self-inspection report, daily supervision and inspection, bad credit records and people's complaints and reports of drug quality management in medical institutions, determine a number of key supervision and inspection units, correspondingly increase the frequency of supervision and inspection, and intensify the quality sampling inspection of drugs used by them. Article 33 Whoever, in violation of the provisions of the first paragraph of Article 6 of these Measures, purchases drugs from an enterprise without a Pharmaceutical Production License or a Pharmaceutical Trading License shall be punished by the pharmaceutical supervisory and administrative department in accordance with the provisions of Article 80 of the Pharmaceutical Administration Law.
In violation of the provisions of the second paragraph of article sixth of these measures, other departments and medical personnel of medical institutions purchase drugs by themselves, and order medical institutions to give corresponding treatment; Those identified as counterfeit and inferior drugs shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Thirty-fourth in violation of the provisions of the first paragraph of Article 12 of these measures, failing to store vaccines as required shall be punished in accordance with the provisions of Article 64 of the Regulations on the Administration of Vaccine Circulation and Vaccination.
Article 35 Whoever, in violation of the provisions of Article 21 of these Measures, uses preparations prepared by other medical institutions without authorization shall be punished in accordance with the provisions of Article 80 of the Drug Administration Law; Those who provide preparations prepared by their own units to other medical institutions without approval shall be punished in accordance with the provisions of Article 84 of the Drug Administration Law.
Article 36 Whoever, in violation of the provisions of Article 22 of these Measures, disposes of counterfeit and inferior drugs or drugs with potential safety hazards without authorization shall be ordered by the pharmaceutical supervisory and administrative department to recover them within a time limit; If the circumstances are serious, it shall be announced to the public.
Article 37 Whoever, in violation of the provisions of Article 23 of these Measures, directly sells prescription drugs to the public by postal sales, Internet transactions, open-shelf counter selection, etc. In accordance with the provisions of Article 42 of the Measures for the Supervision and Administration of Drug Circulation.
Article 38 Whoever, in violation of the relevant provisions of these Measures, conceals facts, fails to truthfully provide articles and records, receipts, medical documents and other information related to the items under inspection, obstructs or refuses to accept supervision and inspection shall be given a heavier punishment in accordance with the provisions of Article 79 of the Regulations for the Implementation of the Drug Administration Law.
Article 39 If a medical institution is under any of the following circumstances, the pharmaceutical supervisory and administrative department shall require it to make rectification within a time limit. Overdue rectification, recorded in the medical institutions of drug quality management credit files, and regularly announced to the public:
(a) failing to establish a quality management system in accordance with the provisions of the first paragraph of Article 4 of these Measures;
(2) Failing to submit the annual self-inspection report on drug quality management in accordance with the provisions of Article 5 of these Measures;
(three) does not meet the provisions of the first paragraph of article seventh and article eighth of these measures;
(four) failing to accept the purchased drugs in accordance with the provisions of Article 9 and Article 10 of these Measures, and making a good record of the acceptance;
(five) failing to establish the procurement system of Chinese herbal pieces in accordance with the provisions of article eleventh of these measures, and purchasing Chinese herbal pieces in violation of the relevant provisions of the state;
(6) Failing to store drugs in accordance with the provisions of Articles 12 and 13 of these Measures;
(seven) failing to maintain drugs in accordance with the provisions of Article fourteenth and Article fifteenth of these measures;
(8) Failing to establish and implement a drug expiration date management system in accordance with the provisions of Article 16 of these Measures;
(nine) does not conform to the provisions of article eighteenth of these measures;
(ten) does not conform to the provisions of article nineteenth of these measures;
(eleven) failing to establish and implement the management system for the disassembly and distribution of minimum packaged drugs in accordance with the provisions of Article 20 of these Measures.
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. Article 41 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government may, in accordance with the provisions of these Measures and in light of local actual conditions, formulate detailed implementation rules.