Article 2 These Measures shall apply to the supervision and management of the quality of medicines in medical institutions within the territory of the People's Republic of China*** and the State of China, and medical institutions shall comply with these Measures in the purchase, storage, deployment and use of medicines.
Third, the State Food and Drug Administration in charge of the national supervision and management of the quality of medicines in medical institutions, local drug supervision and management departments at all levels in charge of the administrative region of the supervision and management of the quality of medicines in medical institutions.
Fourth, medical institutions should establish and improve the quality of drug quality management system, improve the purchase, acceptance, storage, maintenance, deployment and use of drugs and other aspects of the quality management system, do a good job of quality tracking work, and clarify the links in the staff's job responsibilities.
Medical institutions should have a special department responsible for the daily management of drug quality; not set up a special department, it should be appointed to take charge of drug quality management.
Article 5 medical institutions shall submit to the local drug supervision and management department of the drug quality management annual self-examination report, the self-examination report shall include the following:
(a) the implementation of the drug quality management system;
(b) the changes in the preparation of medical institutions;
(c) acceptance of drug supervision and management supervision and inspection and rectification and implementation;
(d) comments and suggestions to the drug supervision and management departments.
The self-examination report shall be submitted before December 31 of the current year. Article 6 Medical institutions must purchase drugs from enterprises with qualifications in drug production and operation.
Drugs used by medical institutions shall be purchased by specialized departments in accordance with the regulations, and it is prohibited for other departments of medical institutions and medical staff to purchase on their own.
Medical institutions importing small quantities of drugs for urgent clinical needs shall be handled in accordance with the relevant provisions of the Drug Administration Law and its implementing regulations.
Article VII of the medical institutions to purchase drugs, shall check the supply unit of the "Drug Manufacturing License" or "Drug Business License" and "Business License", the approval of the drugs sold documents and other relevant documents, and to verify that the sales staff to hold the original authorization and the original identity card.
Medical institutions should be properly preserved for the first time the purchase of drugs stamped with the original seal of the supply unit of the aforementioned supporting documents, the retention period of not less than five years.
Article VIII of the medical institutions should be purchased when the purchase of drugs, the supply unit should be requested, retained legal documents, and the establishment of purchase records, to achieve the ticket, account, goods in line. Legal bills including tax stamps and detailed list, the list must contain the name of the supply unit, the name of the drug, manufacturer, batch number, quantity, price, etc., the retention period of the bills shall not be less than three years.
Article IX medical institutions must establish and implement the purchase and acceptance system, the purchase of drugs should be batch by batch acceptance, and the establishment of a true and complete drug acceptance records.
Medical institutions to accept donations of drugs, emergency drugs from other medical institutions shall also comply with the preceding paragraph.
Article 10 of the drug acceptance records shall include the generic name of the drug, manufacturer, specifications, dosage form, batch number, date of manufacture, expiration date, approval number, supplier, quantity, price, date of purchase, date of acceptance, acceptance conclusions and other content.
Acceptance records must be kept until more than 1 year beyond the expiration date of the drug, but not less than 3 years.
Article XI of the medical institutions shall establish and improve the procurement system of traditional Chinese medicine, in accordance with the relevant provisions of the state purchase of traditional Chinese medicine.
Article XII of the medical institutions shall have a special place and facilities and equipment for the storage of drugs. The storage of medicines shall be in accordance with the conditions indicated in the instructions for medicines.
Medical institutions need to temporarily store drugs in the emergency room, ward nurses station and other places, should be equipped with special cabinets in line with the conditions of drug storage. Special storage requirements, should be equipped with the appropriate equipment.
Article XIII of the medical institutions to store drugs, should be in accordance with the attributes and categories of drugs stored in separate libraries, zones, pallets, and the implementation of color-coded management. Drugs and non-drugs are stored separately; traditional Chinese medicine tablets, proprietary Chinese medicines, chemical drugs are stored separately and categorized; expired, deteriorated, contaminated and other drugs should be placed in the unqualified library (area).
Article XIV of the medical institutions shall formulate and implement the drug storage, maintenance management system, and take the necessary temperature control, moisture, light, ventilation, fire prevention, pest control, rodent prevention, anti-pollution and other measures to ensure the quality of drugs.
Article XV of the medical institutions shall be equipped with drug maintenance personnel, regular inspection and maintenance of stored medicines, monitoring and recording of temperature and humidity in the storage area, maintenance of storage facilities and equipment, and the establishment of the corresponding maintenance files.
Article XVI of the medical institutions shall establish a drug expiration date management system. Drug distribution should follow the "near-expiry first out" principle.
Article XVII of narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs should be stored in strict accordance with relevant administrative regulations, and has the corresponding security measures. Article XVIII of the medical institutions shall be equipped with drug dispensing and use of appropriate, in accordance with the law by the qualification of the pharmacy technicians responsible for prescription review, dispensing work.
Article 19 of the medical institutions for the dispensing of drugs, tools, facilities, packaging supplies, and the area of the dispensing of drugs, shall meet the hygiene requirements and the corresponding requirements of the dispensing.
Article 20 of the medical institutions shall establish the smallest package of drugs split allocation management system to ensure that the quality of drugs can be traced.
Article 21 of the preparation of medical institutions can only be used for the unit. Without the approval of the provincial drug supervision and management department, medical institutions shall not use other medical institutions formulated preparations, and shall not provide other medical institutions with the unit formulated preparations.
Article 22 Medical institutions shall strengthen the quality monitoring of the use of drugs. Counterfeit or substandard drugs are found, they shall immediately stop using them, seal them in place and keep them properly, and promptly report them to the local drug supervision and management department. Before the drug supervision and management department to make a decision, medical institutions shall not be disposed of without authorization.
Medical institutions found that there are hidden safety hazards of drugs, should immediately stop using, and notify the drug manufacturer or supplier, and promptly report to the local drug supervision and management departments. Need to recall, medical institutions should assist drug manufacturers to fulfill the drug recall obligations.
Article 23 Medical institutions shall not use mail sales, Internet transactions, counter open self-service and other ways to sell prescription drugs directly to the public.
Article 24 Medical institutions shall gradually establish an electronic management system covering the purchase, storage, deployment, use of drugs throughout the process of quality control, to achieve traceability of the source of the drugs, the destination can be identified, and docked with the national drug electronic monitoring system.
Article 25 of the medical institutions should be organized annually in direct contact with the medicines personnel health checks, and establish health records. Suffering from infectious diseases or other diseases that may contaminate drugs, shall not engage in direct contact with drugs.
Article 26 The medical institutions shall regularly organize the purchase of drugs, storage, maintenance, acceptance, deployment, use of personnel to participate in pharmaceutical regulations and professional knowledge of pharmacy training, and the establishment of training files. Article 27 The drug supervision and management department shall supervise and inspect the purchase, storage, deployment and use of drugs in medical institutions quality, and establish the supervision and inspection files of medical institutions.
Supervision and inspection of the situation and the results shall be formed into a written record, signed by the supervision and inspection of the unit to be inspected after feedback. Problems found in the inspection need to be dealt with by other departments, should be transferred in a timely manner.
Article 28 of the medical institutions shall actively cooperate with the drug supervision and management departments in accordance with the law on the purchase of drugs, storage, deployment and use of quality supervision and inspection, and truthfully provide the items and records related to the matters being inspected, vouchers, as well as medical documents and other information, and shall not be refused and concealed.
Article 29 The drug supervision and management department shall strengthen the supervision and sampling of drugs in medical institutions.
The national or provincial drug supervision and management departments shall regularly issue bulletins to publicize the results of sampling and testing of the quality of medicines in medical institutions.
Objection to the quality of the results of random testing, the re-examination procedures in accordance with the relevant provisions.
Article 30 The drug supervision and management department shall, in accordance with the actual situation, establish a credit file of drug quality management of medical institutions, record the results of daily supervision and inspection, investigation and handling of violations.
Article 31 The drug supervision and management department receives the consultation, complaint, report on the quality of drugs in medical institutions, shall promptly accept, and verify, reply, and deal with; not belonging to the department's responsibilities, it shall be notified in writing and transferred to the relevant departments to deal with.
Article 32 of the drug supervision and management departments can be based on the annual self-inspection report of the quality of drug management of medical institutions, routine supervision and inspection, bad credit record and the people's complaints, reports, to determine a number of key supervision and inspection units, and accordingly increase the frequency of supervision and inspection of its use of drugs to increase the quality of sampling and testing efforts. Article 33 violation of the provisions of paragraph 1 of Article 6 of these Measures, from the absence of "Drug Production License", "Drug Business License" of the enterprise purchase of drugs, by the drug supervision and management department in accordance with the "Drug Administration Law," Article 80 of the provisions of the penalties.
In violation of the provisions of the second paragraph of Article 6 of these Measures, other departments of medical institutions and medical staff to purchase their own medicines, the medical institutions shall be ordered to give the appropriate treatment; recognized as fake or shoddy drugs, shall be punished in accordance with the relevant provisions of the "Drug Administration Law".
Article 34 violation of the provisions of Article 12, paragraph 1 of these measures, not in accordance with the requirements of the storage of vaccines, in accordance with the "Regulations on the Administration of Vaccine Circulation and Preventive Vaccination," Article 64 shall be punished.
Article 35 violation of the provisions of Article 21 of these Measures, the unauthorized use of preparations prepared by other medical institutions, in accordance with the provisions of Article 80 of the Drug Administration Law shall be punished; unauthorized provision of preparations prepared by the unit to other medical institutions, in accordance with the provisions of Article 84 of the Drug Administration Law shall be punished.
Article 36 violation of the provisions of Article 22 of these Measures, unauthorized disposal of counterfeit or shoddy drugs or drugs with hidden safety risks, the drug supervision and management department shall order the recovery of a limited period of time; if the circumstances are serious, to the public.
Article 37 Violation of the provisions of Article 23 of these measures, the use of mail sales, Internet transactions, counter open self-service sales of prescription drugs directly to the public, in accordance with the "supervision and management of the circulation of medicines," Article 42 of the provisions of the penalties.
Article 38 Violation of the relevant provisions of these Measures, and concealment of facts, not truthfully provide items and records, vouchers, and medical instruments and other information related to the matters being inspected, obstruction or refusal to accept the supervision and inspection, in accordance with the provisions of Article 79 of the "Regulations for the Implementation of the Pharmaceutical Affairs Law" shall be subject to heavier penalties.
Article 39 If a medical institution has one of the following circumstances, the drug supervision and management department shall require it to rectify the situation within a certain period of time, and if it fails to do so, it shall be recorded in the credit file of the medical institution's quality management of drugs and shall be announced to the society regularly:
(1) Failure to establish a quality management system in accordance with the provisions of Paragraph 1 of Article 4 of these Measures;
(2) Failure to submit an annual self-inspection report on the quality management of drugs as stipulated in Article 5 of these Measures. Submission of annual self-inspection reports on drug quality management;
(3) Failure to request certificates and tickets for inspection in accordance with the provisions of Article 7, Paragraph 1 and Article 8 of these Measures;
(4) Failure to conduct acceptance of purchased drugs in accordance with the provisions of Articles 9 and 10 of these Measures, and to make a good record of the acceptance;
(5) Failure to set up a system for purchasing traditional Chinese medicinal herbs and drinking tablets in accordance with the provisions of Article 11 of these Measures. Violation of the relevant provisions of the State purchase of traditional Chinese medicine tablets;
(6) failure to store drugs in accordance with the provisions of Article 12 and Article 13 of these Measures;
(7) failure to maintain the drugs in accordance with the provisions of Article 14 and Article 15 of these Measures;
(8) failure to establish and implement the management system of the expiration date of drugs in accordance with the provisions of Article 16 of these Measures;
(9) failure to In accordance with the provisions of Article 18 of these Measures staffing;
(10) not in accordance with the provisions of Article 19 of these Measures;
(11) not in accordance with the provisions of Article 20 of these Measures to establish the smallest packaged medicines split and dispensing management system and implementation.
Article 40 The drug supervision and management department shall strengthen the education, training and management of the staff of this department, and urge them to perform their duties properly. Where the failure to perform the duties specified in these measures or abuse of power, dereliction of duty, favoritism and malpractice, shall, in accordance with the law on the directly responsible officer in charge and other persons directly responsible for the appropriate administrative sanctions; suspected of committing a crime, be transferred to the judicial organs. Article 41 Provinces, autonomous regions, municipalities directly under the Central Drug Administration can combine the local actual situation, according to the provisions of the Measures to formulate implementation details.
Legal basis:
"Drug Production Supervision and Administration" Article 5 of the State Drug Administration in charge of the national supervision and management of drug production, the provinces, autonomous regions and municipalities directly under the Central Drug Administration to supervise and guide the supervision and management of drug production. Provinces, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the supervision and management of drug production in the administrative region, bear the production of drugs in the process of licensing, inspection and punishment.