Article 2 (Scope of Application) These Measures are applicable to the drug quality supervision and management of medical institutions in People's Republic of China (PRC).
Article 3 (Division of Responsibilities) The US Food and Drug Administration is in charge of the supervision and administration of drug quality in medical institutions throughout the country. The local food and drug supervision and administration departments at or above the county level shall be responsible for the supervision and administration of drug quality in medical institutions within their respective administrative areas. Article 4 (Legal Channels) Medical institutions must purchase drugs from legal enterprises with corresponding pharmaceutical production and business qualifications, except for Chinese herbal medicines that are not subject to the approval number management.
(Complete license) When purchasing drugs, medical institutions should first verify and verify the drug production license or drug business license, business license, power of attorney of the supplier, and the approval documents of the drugs purchased. For drugs purchased for the first time, a copy of the above information stamped with the original seal of the supplier shall be properly kept.
Article 5 (Bill Management) When purchasing drugs, medical institutions shall obtain legal bills (tax bills and detailed lists) and keep them. The list must include the name of the supplier, the generic name of the drug, the manufacturer, the batch number, the quantity and the price. The retention period of bills should be greater than 1 year and not less than 3 years.
Article 6 (Administration of Chinese Herbal Pieces) Medical institutions shall abide by the relevant provisions of the Standard for Administration of Chinese Herbal Pieces in Hospitals, and establish and improve the procurement system of Chinese Herbal Pieces; According to the relevant regulations of the food and drug administration, it is strictly forbidden to buy Chinese herbal pieces from legal suppliers or other markets.
Article 7 (Storage Requirements) Medical institutions shall set up corresponding special storage places and facilities to store medicines.
(Special area) If medical institutions need to temporarily store drugs in emergency rooms, ward nurses' stations and other places, they should be equipped with counters that meet the conditions for drug storage. If there are special storage requirements, corresponding equipment shall be provided.
Article 8 (Classified Storage) When storing drugs, medical institutions should store them in different warehouses, districts and stacks according to the attributes and categories of drugs, and implement color-coded management. Drugs and non-drugs are stored separately; Chinese herbal medicines, Chinese herbal pieces, chemicals and Chinese patent medicines are stored separately and classified; Expired, deteriorated, polluted and other drugs should be put into the unqualified library (area); Narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, precursor chemicals and inflammable, explosive, corrosive and other dangerous drugs shall be stored in accordance with relevant regulations, and necessary safety measures shall be taken.
Article 9 (Refrigeration) Medical institutions shall store drugs according to the storage conditions indicated in the drug instructions. The drug instructions require that drugs stored in cold storage should be stored in cold storage facilities and equipment, and whether they meet the corresponding conditions should be checked and recorded during acceptance and maintenance.
Article 10 (Maintenance System) Medical institutions shall formulate and implement a management system for drug storage and maintenance, 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.
Article 11 (Maintenance) Medical institutions shall be equipped with drug maintenance personnel to regularly inspect and maintain the stored drugs, monitor and record the temperature and humidity in the storage area, maintain the storage facilities and equipment, and establish corresponding maintenance files.
Twelfth medical institutions should establish an effective drug management system. Drug distribution should follow the principles of "first in, first out" and "first out in the near future". Article 13 (Hygienic Requirements for Dispensing Drugs) The tools, facilities, packages and areas used by medical institutions for dispensing drugs shall meet the hygiene requirements and the corresponding dispensing requirements.
Article 14 (Requirements for Disassembly and Dispensing) If a medical institution needs to disassemble and dispense the original drugs with minimum packaging, it shall make records of disassembly and dispensing. The words "please take it within the prescribed time limit" must be marked on the packaging bag of unpacked drugs, as well as the general name, specification, usage, dosage, batch number, name of medical institution, etc. The label of the drug should be marked. If there are other special requirements, it shall be stated in writing.
Article 15 (Administration of Counterfeit and Inferior Drugs and Expired Drugs) Medical institutions shall not use counterfeit and inferior drugs.
(Report on Counterfeit and Inferior Drugs) If a medical institution finds counterfeit and inferior drugs, it shall immediately stop using them and report to the local food and drug supervision and administration department in time.
(Report on Suspicious Drugs) When a medical institution finds a drug with suspicious quality, it shall suspend its use and report to the local food and drug supervision and administration department in time.
(Reporting the Disposal of Drugs) Before the food and drug supervision and administration department makes a treatment, medical institutions shall not sell, destroy or return the above drugs to enterprises.
Article 16 (Clinical Trial Drugs) Medical institutions must use clinical trial drugs in strict accordance with the prescribed scope and may not sell them.
Article 17 (Medical Advertisement of Drugs) Medical institutions shall not use medical advertisements to publicize and recommend drugs, and hospital preparations prepared by them shall not publish advertisements; Do not use news reports, medical information service specials (columns), the Internet and other forms to advertise and recommend drugs.
Article 18 (Disguised Sales) Medical institutions shall not operate or operate drugs in disguised form by postal sales, sales without prescription (or forged prescription), out-of-range use, free consultation on counter opening, charity sale, consultation, trial, trade fair, Internet trading and other means.
Article 19 (Individual Sale of Drugs) Staff of medical institutions shall not sell drugs and hospital preparations without permission. Article 20 (Supervision and Inspection) The food and drug supervision and administration department shall regularly supervise and inspect the quality of drugs in medical institutions, including the purchase, preservation, unpacking and preparation of drugs.
(Handling of Inspection Results) The results of supervision, inspection and handling shall be recorded in writing and filed after being signed by the supervision and inspection personnel. If the problems found in the inspection need to be handled by other departments, they shall be transferred in time.
(Inspection Discipline) Supervision and inspection activities shall not interfere with the normal diagnosis and treatment activities of medical institutions, and shall not ask for or accept the property of the inspected unit or seek other illegitimate interests.
Article 21 (Obligation to Cooperate with Inspection) Medical institutions shall actively cooperate with the food and drug supervision and administration departments to supervise and inspect the quality of drugs according to law, truthfully provide articles, records, vouchers, medical documents and other materials related to the items under inspection, and shall not hinder or refuse to accept supervision and inspection.
Article 22 (Responsible Subject) A medical institution shall set up a special institution or designate a person to be responsible for the drug quality management of its own unit, establish and implement a drug quality management system, and be responsible for its drug quality.
Article 23 (Quality Tracking) Medical institutions shall establish a drug quality tracking management system to ensure that quality tracking can be carried out quickly and accurately.
Article 24 (Electronic Management System) Medical institutions at or above the county level shall establish an electronic management system that covers and records the quality information related to the process of drug procurement, storage and deployment.
Article 25 (Health Records) Every year, a medical institution shall organize personnel who have direct contact with drugs to have a health check-up and establish a health record. Persons who are found to be suffering from mental illness, infectious diseases and other diseases that may pollute drugs shall be transferred from their posts where they are in direct contact with drugs.
Article 26 (Provisions on Sampling Inspection of Essential Drugs) The food and drug supervision and administration department shall carry out full coverage supervision sampling inspection on the quality of drugs listed in the national list of essential drugs, and strengthen supervision sampling inspection on the quality of essential drugs in pharmaceutical production enterprises and trading enterprises.
Article 27 (Quality Announcement) The national or provincial food and drug supervision and administration department must publicly release the results of sampling inspection of drug quality (including national essential drugs) of pharmaceutical production enterprises and trading enterprises in the form of drug quality announcement.
Objection to quality sampling results and reinspection procedures shall be implemented in accordance with relevant regulations.
Article 28 (Disposal of Adverse Reactions/Events) When serious adverse drug reactions or drug quality and safety accidents occur, the food and drug supervision and administration department shall promptly deal with them in accordance with the Drug Administration Law, the Measures for the Administration of Reporting and Monitoring of Adverse Drug Reactions and relevant emergency plans. Article 29 (Disposal through Illegal Channels) Anyone who, in violation of the provisions of the first paragraph of Article 4 of these Measures, purchases drugs from an enterprise or individual without a Pharmaceutical Production License or a Pharmaceutical Trading License, or in violation of the provisions of Article 6 of these Measures, purchases Chinese herbal pieces from the specialized market of Chinese herbal medicines or other markets, shall be punished by the food and drug supervision and administration department at or above the county level in accordance with the relevant provisions of the Drug Administration Law.
Article 30 (Handling of Minor Violations: Record, Preservation and Maintenance of Purchase) If a medical institution is under any of the following circumstances, the food and drug supervision and administration department at or above the county level shall give it a warning and order it to make corrections; In serious cases, issue a notice:
(a) does not meet the provisions of the second paragraph of article fourth and article fifth of these measures;
(2) Failing to store drugs in accordance with the provisions of Articles 7 and 8 of these Measures;
(3) Failing to maintain drugs in accordance with the provisions of Articles 10 and 11 of these Measures;
(four) does not meet the provisions of article fourteenth of these measures.
Article 31 (Treatment of Violation of Refrigeration) Whoever violates the provisions of Article 9 of these Measures and fails 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; Failing to store narcotic drugs and psychotropic drugs as required, it shall be punished in accordance with the provisions of Article 72 of the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs; If other drugs are not stored as required, the food and drug supervision and administration department at or above the county level shall give a warning and order it to make corrections; If no correction is made within the time limit, a fine of more than 5000 yuan 1000 yuan will be imposed.
Article 32 (Involving illegal quality and failure to perform obligations) If a medical institution fails to manage expired drugs in accordance with the provisions of Article 12 of these Measures, the food and drug supervision and administration department at or above the county level shall give it a warning, order it to make corrections and impose a fine of 1 000 yuan:
Article 33 (Disposal of Counterfeit and Inferior Drugs) If a medical institution intentionally uses counterfeit and inferior drugs in violation of the first paragraph of Article 15 of these Measures, it shall be punished in accordance with the relevant provisions of the Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law; Anyone suspected of committing a crime shall be transferred to the public security organ for criminal responsibility. Whoever, in violation of the provisions of the fourth paragraph of Article 15 of these Measures, sells, destroys or returns counterfeit and inferior drugs or drugs with questionable quality to enterprises without authorization shall be ordered by the food and drug supervision and administration department at or above the county level to recover within a time limit and be fined between 6,543,800 yuan and 30,000 yuan.
Article 34 (Disposal of Clinical Trial Drugs) Whoever, in violation of the provisions of Article 16 of these Measures, sells or expands the use of clinical trial drugs shall be punished as selling counterfeit drugs, and the food and drug supervision and administration department at or above the county level shall impose penalties in accordance with the relevant provisions of the Drug Administration Law.
Article 35 (Handling of Medical Advertisements for Drugs) Where illegal advertisements are published in violation of the provisions of Article 17 of these Measures, the original advertising examination and approval authority shall make an announcement according to law, take back the advertisement approval number and transfer it to the administrative department for industry and commerce for handling.
Article 36 (Disposal of Disguised Sales) Whoever, in violation of the provisions of Article 18 of these Measures, sells drugs in disguised form shall be punished by the food and drug supervision and administration department at or above the county level in accordance with the relevant provisions of the Drug Administration Law.
Article 37 (Handling of Individual Sales of Drugs) Where the staff of medical institutions sell drugs and hospital preparations privately in violation of the provisions of Article 19 of these Measures, the food and drug supervision and administration department at or above the county level shall impose administrative penalties on the persons involved in the case in accordance with the relevant provisions of the Drug Administration Law.
Article 38 (Illegal Supervision) If the food and drug supervision and administration department and its staff commit any of the following acts, the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law:
(a) failing to carry out supervision and inspection and sampling inspection in accordance with the provisions of Article 20 and Article 26 of these Measures;
(2) Failing to announce the results of spot checks on drug quality to the public in accordance with the provisions of Article 27 of these Measures;
(three) there are other acts of favoritism, dereliction of duty, abuse of power. Article 39 (Interpretation of Terminology) The terms involved in these Measures have the following meanings:
Medical institutions refer to various medical units that have obtained the Practice License of Medical Institutions in accordance with the Regulations on the Administration of Medical Institutions, including hospitals, health centers, sanatoriums, maternal and child health centers, outpatient departments, clinics, health centers (rooms, stations), infirmary, emergency centers (stations), preventive hospitals (stations), sanatoriums (stations) and other units.
Article 40 (Exception) Where there are other provisions in relevant laws, regulations and rules on the supervision and administration of the use of drugs, vaccines and military drugs subject to special management, those provisions shall prevail.
Article 41 (Effective Date) These Measures shall come into force on xx, xxxx.