Article 2 (Scope of Application) 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.
Article 3 (division of responsibilities) The State Food and Drug Administration in charge of the supervision and management of the quality of medicines in medical institutions across the country. Local food and drug supervision and management departments at or above the county level is responsible for the supervision and management of the quality of medicines in medical institutions within the administrative region. Article IV (channel legal) medical institutions must be from the corresponding drug production, business qualifications of legitimate enterprises to purchase drugs, not the implementation of the approval number management of Chinese herbal medicines, except.
(Full license) medical institutions to purchase drugs, should first check and verify the supply unit's drug production license or drug license, business license, power of attorney, as well as the approval of the purchased drugs and other valid documents. For the first purchase of drugs, should be properly preserved with the original seal of the supply unit copies of the above materials.
Article 5 (management of bills) medical institutions should purchase drugs for legitimate bills (tax stamps and a detailed list) and retained, the list must contain the name of the supply unit, the generic name of the drug, the manufacturer, batch number, quantity, price and other content, the bills are kept until more than the expiration date of the drug for one year, and shall not be less than three years.
Article VI (management of traditional Chinese medicine tablets) medical institutions using traditional Chinese medicine tablets should comply with the relevant provisions of the "Hospital Chinese Medicine Tablets Management Code," the establishment of a sound procurement system of traditional Chinese medicine tablets; in accordance with the relevant provisions of the Food and Drug Administration to purchase from the legitimate supply units of traditional Chinese medicine tablets, it is strictly prohibited to purchase from the professional market of Chinese herbal medicines or other markets for the purchase of traditional Chinese medicine tablets.
Article VII (storage requirements) medical institutions shall set up appropriate special storage places and facilities for storing drugs.
(Special area) 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. There are special storage requirements, should be equipped with the appropriate equipment.
Article VIII (classification and storage) medical institutions to store medicines, should be in accordance with the attributes and categories of drugs stored in separate libraries, zones, pallets, and the implementation of color-coded management. Separate storage of drugs and non-drugs; Chinese herbal medicines, Chinese medicinal herbs, Chinese medicinal tablets, chemicals, proprietary Chinese medicines are stored separately, categorized; expired, spoiled, contaminated and other medicines should be placed in the unqualified library (area); narcotic drugs, psychotropic substances, toxic medicines for medical use, radiopharmaceuticals, narcotics, toxic chemicals, as well as flammable, explosive, strong corrosive and other hazardous medicines should be stored in accordance with the relevant provisions, and to take the necessary safety measures.
Article IX (Refrigeration) Medical institutions shall store drugs in accordance with the storage conditions indicated in the drug instructions. Drug instructions require refrigerated storage of drugs should be stored using refrigerated facilities and equipment, acceptance, maintenance should be checked whether the appropriate conditions and records.
Article 10 (maintenance system) medical institutions shall develop and implement drug storage, maintenance management system, and take the necessary temperature control, moisture, light, ventilation, fire prevention, pest control, rodent prevention, anti-pollution measures to ensure the quality of medicines.
Article 11 (maintenance) Medical institutions shall have drug maintenance personnel to regularly inspect and maintain the stored drugs, monitor and record the temperature and humidity of the storage area, maintain the storage facilities and equipment, and establish corresponding maintenance files.
Article 12 (management of near-expiry drugs) Medical institutions shall establish an expiration date drug management system. Drug distribution should follow the "first in, first out", "near expiration date first out" principle. Article XIII (dispensing health requirements) medical institutions for the dispensing of medicines tools, facilities, packaging supplies and the area of the dispensing of medicines, shall meet the health requirements and the corresponding dispensing requirements.
Article XIV (zero requirements) medical institutions need to split the original minimum packaging of medicines dispensed, should make a good record of the split. Split the bag of drugs must indicate "please take within the period of use prescribed by the doctor" words, and indicate the generic name of the drug, specifications, usage, dosage, batch number, the name of the medical institution. There are other special requirements, should be stated in writing.
Article 15 (fake and inferior drugs and expired management) Medical institutions shall not use fake or inferior drugs.
(Counterfeit and substandard drugs report) medical institutions found counterfeit drugs, substandard drugs, shall immediately stop using, and promptly report to the local food and drug supervision and management department.
(Suspicious drug report) medical institutions found that the quality of the drug is suspicious, should suspend the use of timely report to the local food and drug supervision and management departments.
(Report on the disposal of drugs) Before the food and drug supervision and management departments to make a disposition, medical institutions shall not sell, destroy or return the above drugs to the enterprise.
Article 16 (Clinical Trial Drugs) Medical institutions must use clinical trial drugs in strict accordance with the scope of the provisions, and shall not sell them.
Article XVII (Medical Advertisements Involving Drugs) Medical institutions shall not use medical advertisements to promote and recommend drugs, and their formulated hospital preparations shall not be advertised; they shall not use news reports, medical information services, thematic programs (columns), the Internet and other forms of advertising and recommending drugs.
Article 18 (Disguised Sales) Medical institutions shall not operate or disguise the operation of medicines in other ways, such as selling by mail, selling without (or forging) prescriptions, using in excess of the scope of use, open-shelf self-selection over the counter and charity clinics, charity sales, consultations, trials, trade fairs and Internet transactions.
Article 19 (personal sale of medicines) staff of medical institutions shall not sell drugs and hospital preparations privately. Article 20 (Supervision and Inspection) Food and Drug Administration shall regularly supervise and inspect the quality of medicines in medical institutions, including the purchase, preservation, unpacking and preparation of medicines.
(Inspection results processing) Supervision and inspection of the situation and the results of processing should be formed into a written record, signed by the supervision and inspection personnel and filed. Problems found in the inspection need to be handled by other departments, should be transferred in a timely manner.
(Inspection Discipline) Supervision and inspection activities shall not impede the normal diagnosis and treatment of medical institutions, shall not solicit or accept the property of the inspected unit, and shall not seek other improper interests.
Article 21 (obligation to cooperate with the inspection) medical institutions shall actively cooperate with the food and drug supervision and management departments in accordance with the law to supervise and inspect the quality of medicines, and truthfully provide items related to the matters being inspected, and records, vouchers, and medical documents and other information, and shall not impede or refuse to accept the supervision and inspection.
Article 22 (responsible for the main body) medical institutions should set up a specialized agency or designate a person responsible for the unit of drug quality management, establish and implement a sound drug quality management system, responsible for the quality of its drugs.
Article 23 (quality tracking) Medical institutions shall establish a drug quality tracking management system to ensure that the quality can be tracked quickly and accurately.
Article 24 (electronic management system) Medical institutions at or above the county level shall establish an electronic management system covering the recording of quality information related to the process of drug purchase, storage and deployment.
Article 25 (health records) medical institutions should be organized annually to direct contact with the drug personnel health checks, and establish health records. Found to suffer from mental illness, infectious diseases and other diseases that may contaminate the drugs of personnel, should be transferred out of direct contact with drugs.
Article 26 (basic medicines sampling provisions) Food and Drug Administration for the inclusion of the national essential medicines directory of the quality of drug varieties to implement full-coverage supervision and sampling, and to strengthen the quality of drug manufacturers, business enterprises to supervise the quality of basic medicines sampling.
Article 27 (Quality Announcement) The results of sampling and testing of the quality of drugs (including national essential drugs) of drug manufacturers and business enterprises, the national or provincial food and drug supervision and management departments must be in the form of drug quality announcements publicly released to the community.
Quality sampling results of objections, retesting procedures in accordance with the relevant provisions.
Article 28 (Adverse Reaction/Event Disposal) In the event of serious adverse drug reactions or drug quality and safety accidents, the food and drug supervision and management departments shall, in accordance with the "Drug Administration Law", "Administrative Measures for the Reporting and Monitoring of Adverse Drug Reactions" and the provisions of the relevant emergency response plan, timely disposal. Article 29 (illegal channels to deal with) violation of the provisions of paragraph 1 of Article 4 of these Measures, from the absence of "drug production license", "drug business license" of enterprises or individuals to purchase drugs, violation of the provisions of Article 6 of these Measures, from the professional market of Chinese herbal medicines or other marketplace to purchase Chinese medicine tablets, by the food and drug supervision and management departments at or above the county level in accordance with the "Drug Administration Law" relevant provisions of the penalties.
Article 30 (minor violations: purchase records, preservation, maintenance) medical institutions in one of the following cases, the food and drug supervision and management departments at or above the county level shall issue a warning and order rectification; if the situation is serious, a notice:
(a) not in accordance with the provisions of Article 4, paragraph 2, Article 5 of these Measures to ask for inspection;
(b) not in accordance with the provisions of Article 7, Article 8, storage of drugs Article VII, Article VIII of the provisions of the storage of drugs;
(C) not in accordance with the provisions of Article 10, Article 11 of the maintenance of drugs;
(D) not in accordance with the provisions of Article XIV of these measures to do a good job of record splitting.
Article 31 (refrigeration violations) violation of the provisions of Article 9 of these Measures, not in accordance with the requirements of the storage of vaccines, in accordance with the "Regulations on the Circulation of Vaccines and Preventive Vaccination Management", Article 64 of the punishment; not in accordance with the requirements of the storage of narcotic drugs and psychotropic substances, in accordance with the "Narcotic Drugs and Psychotropic Substances Administration Regulations", Article 72 of the punishment; not in accordance with the requirements of the storage of other medicines, the food and drug supervision and management department at or above county level shall impose a warning. Food and drug supervision and management department shall issue a warning and order rectification; if no rectification is made, a fine of not less than 5,000 yuan and not more than 10,000 yuan shall be imposed.
Article 32 (involving quality violations and failure to fulfill obligations to deal with) medical institutions failing to manage expiration date medicines in accordance with the provisions of Article 12 of these Measures, the food and drug supervision and management department at or above the county level shall issue a warning, order correction, and impose a fine of not more than RMB 10,000 yuan:
Article 33 (dealing with counterfeit and substandard medicines) in violation of the provisions of the first paragraph of Article 15 of these Measures, a medical institution intentionally using Counterfeit drugs, substandard drugs, in accordance with the "Drug Administration Law", "Drug Administration Law Enforcement Regulations" relevant provisions of the penalties; suspected of committing a crime, the transfer of the public security organs to pursue criminal responsibility. Violation of the provisions of paragraph 4 of Article 15 of these Measures, unauthorized sale, destruction, return of enterprise fake or shoddy drugs or drugs of doubtful quality, by the food and drug supervision and management departments at or above the county level shall order the recovery of the deadline, and impose a fine of 10,000 yuan or more than 30,000 yuan.
Article 34 (handling of clinical trial drugs) Violation of the provisions of Article 16 of these Measures, the sale or expansion of the scope of the use of clinical trials of drugs, according to the sale of counterfeit medicines, by the food and drug supervision and management departments at or above the county level shall be punished in accordance with the relevant provisions of the <
Article 35 (handling of drug-related medical advertisements) Violation of the provisions of Article 17 of these Measures, the release of illegal advertisements, by the original advertisement approval authority shall be announced according to law, withdraw the advertising approval number, and transferred to the administration for industry and commerce to deal with.
Article 36 (disguised sales processing) Violation of the provisions of Article 18 of these measures, disguised sales of drugs, by the food and drug supervision and management departments at or above the county level shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Article 37 (personal sale of drugs) violation of the provisions of Article 19 of this approach, the staff of medical institutions to sell drugs and hospital preparations privately, by the food and drug supervision and management departments at or above the county level in accordance with the "Drug Administration Law" to the relevant provisions of the staff involved in administrative penalties.
Article 38 (regulatory violations) The food and drug supervision and management departments and their staff have one of the following behaviors, the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions:
(a) failure to implement supervision and inspection, sampling and testing in accordance with the provisions of Article 20 and Article 26 of these measures;
(b) failure to publish the drug quality sampling test to the public in accordance with the provisions of Article 27 of these measures Provisions to the community to publish the results of drug quality sampling and testing;
(3) other favoritism, negligence, abuse of power. Article 39 (Interpretation of Terms) These measures involve the meaning of the terms as follows:
The medical institutions refers to the provisions of the "Regulations on the Administration of Medical Institutions" to obtain the "license to practice in medical institutions" at all levels of various types of medical units, including hospitals, health centers, sanatoriums, maternity and child health care centers, outpatient clinics, clinics, health centers (rooms, stations), clinics, first aid center (station), prevention and treatment of hospitals (stations), Nursing homes (stations) and other units.
Article 40 (Exceptions) The supervision and management of the use of medicines, vaccines and medicines for military use under special management shall be governed by the relevant laws, regulations and rules where they provide otherwise.
Article 41 (effective date) These Measures shall come into force on xxxx xxxx.