Article 2 These Measures shall apply to the administration of drugs and medical devices in medical institutions within the administrative area of this province.
The medical institutions mentioned in the preceding paragraph include hospitals, maternal and child health centers, health centers, sanatoriums, outpatient departments (including individuals), clinics (including individuals), health centers (rooms), emergency centers (stations), disease prevention hospitals (stations), sanatoriums (stations), and community health service centers (stations).
Article 3 The food and drug supervision and administration department of the provincial people's government is responsible for the supervision and administration of drugs and medical devices in medical institutions in the province. The food and drug supervision and administration department of the municipal, county and district people's governments shall be responsible for the supervision and administration of drugs and medical devices in medical institutions within their respective administrative areas.
The relevant administrative departments of the people's governments at or above the county level shall be responsible for the supervision and administration of drugs and medical devices in medical institutions within their respective functions and duties.
Article 4 Medical institutions shall allocate drugs according to the prescriptions of practicing doctors, assistant practicing doctors or rural doctors who have obtained the practice registration certificate of rural doctors within the scope of medical treatment subjects and family planning technical services approved according to law.
Article 5 A medical institution may, according to the relevant provisions of the state, set up a pharmacy or medicine cabinet within the scope of diagnosis and treatment and medication approved according to law.
The establishment of pharmacies or medicine cabinets by medical institutions shall conform to the management norms formulated by the food and drug supervision and administration department of the provincial people's government.
Sixth individual clinics, clinics and other medical institutions shall not be equipped with drugs other than commonly used drugs and emergency drugs. The range and varieties of commonly used drugs and emergency drugs shall be formulated and published by the health administrative department of the provincial people's government in conjunction with the food and drug supervision and administration department of the provincial people's government.
The scope of drug use of family planning technical service institutions shall be consistent with the approved scope of service, service items and surgical operations, and drugs outside the list of essential drugs of family planning technical service institutions shall not be used, except those that have obtained the Medical Practice License. The list of essential drugs of family planning technical service institutions shall be formulated and published by the food and drug supervision and administration department of the provincial people's government in conjunction with the family planning administrative department of the provincial people's government.
Article 7 The scope and varieties of drugs used by medical institutions as stipulated in Article 6 of these Measures shall not be changed without authorization. If it is really necessary to change, it shall be reported to the local food and drug supervision and administration department, the health administrative department or the family planning administrative department for approval according to law.
Article 8 Medical institutions shall purchase medicines from pharmaceutical production and trading enterprises with Pharmaceutical Production License or Pharmaceutical Trading License, except for Chinese herbal medicines that are not subject to the approval number management. Village clinics and individual clinics can also entrust township hospitals to purchase drugs or distribute them by local drug distribution centers.
Township hospitals purchasing drugs shall hold the power of attorney issued by village clinics and individual clinics, and accept the supervision and inspection of local food and drug supervision and management departments.
Article 9 When purchasing drugs, medical institutions shall establish a system of incoming inspection and acceptance, and verify the drug certificate and other packaging marks; Those that do not meet the specified requirements shall not be purchased.
Article 10 Medical institutions shall, in accordance with the provisions of laws and regulations, establish true and complete records of drug procurement. The storage time of drug procurement records shall not be less than 3 years; If the validity period of the drug exceeds 3 years, it shall be kept until 1 year after the expiration of the validity period of the drug.
Article 11 Medical institutions shall prepare drugs by prescription, and shall not deal in drugs by mail, forged prescriptions, counter opening, free clinic, charity sale, consultation, trial, trade fair, etc.
Article 12 Medical institutions shall formulate and implement a drug storage system, store drugs by category according to the relevant provisions on drug quality and safety, and take measures such as cold storage, anti-freezing, moisture-proof, light-proof, ventilation, fire prevention, insect prevention and rat prevention to ensure the quality of drugs.
Medical institutions should regularly maintain the stored drugs.
Thirteenth medical institutions to prepare drugs dispensing tools, packaging materials, containers and working environment should meet the hygiene requirements to prevent drugs from being contaminated.
If a medical institution needs to disassemble the original minimum package of drugs when preparing drugs, it shall make disassembly records and keep the original minimum package and drug instructions until the end of sales. The name, specification, usage, dosage and expiration date of the drug shall be marked on the packaging surface of the unpacked drug.
Article 14 With the approval of the food and drug supervision and administration department of the provincial people's government, traditional Chinese medicine preparations prepared by hospital medical institutions may be entrusted to pharmaceutical production enterprises or preparation rooms of medical institutions with preparation licenses.
Fifteenth internal departments of medical institutions shall not set up pharmacies without permission, and medical personnel of medical institutions shall not sell drugs and preparations without permission.
Without approval, medical institutions shall not use preparations prepared by other medical institutions.
Article 16 Medical institutions shall not use counterfeit or inferior drugs.
If a medical institution finds fake or inferior drugs in the process of drug use, it shall immediately stop using them and report to the local food and drug supervision and administration department in time, and shall not dispose of them without authorization.
Medical institutions should suspend the use of drugs with suspicious quality and send them to drug inspection institutions for inspection; Those identified as counterfeit or inferior drugs after inspection shall report to the local food and drug supervision and administration department in time.
Article 17 A medical institution shall conduct an annual health check-up for those who have direct contact with drugs, and establish health records. Persons suffering from infectious diseases, suspected infectious diseases and other diseases that may contaminate drugs shall not engage in direct contact with drugs.
Personnel engaged in drug procurement, storage, maintenance, acceptance and deployment in medical institutions shall receive professional training and continuing education. If the state stipulates that professional qualifications should be obtained, such provisions shall prevail.
Article 18 Medical institutions shall not use medical services to advertise drugs, and the preparations prepared by them shall not publish advertisements.
Article 19 A medical institution shall purchase medical devices from a manufacturing enterprise or an operating enterprise with a Medical Device Manufacturing Enterprise License or a Medical Device Operating Enterprise License.
When purchasing medical devices, medical institutions shall establish a system of incoming inspection and acceptance, verify the certificate of medical devices and other packaging labels, and shall not purchase medical devices that are unregistered, have no certificate of conformity, expire, fail, be eliminated or fail to meet the registration standards.
Twentieth medical institutions shall establish a true and complete procurement record when purchasing medical devices, and the record shall include the following contents:
(1) The trademark and name, specification (model), batch number and expiration date of the medical device and the sterilization batch number of the sterilized product shall also be recorded;
(2) Purchase quantity, purchase price and purchase date;
(3) A copy of the medical device registration certificate, medical device manufacturing enterprise license or medical device business license of the manufacturer, supplier or supplier;
(four) the acceptance conclusion, the signature or seal of the manager and the person in charge.
The storage time of procurement records shall not be less than 1 year after the expiration of the product validity period or after the termination of use, and the procurement records of implantable medical devices shall be kept permanently.
Twenty-first medical institutions to store medical devices warehouse, shall comply with the laws, regulations, rules or provisions of the food and drug supervision and management department of the provincial people's government conditions.
Twenty-second medical institutions shall not use medical devices that are unregistered, without certificates, expired, invalid, eliminated or do not meet the registration standards. Medical institutions shall not expand the scope of use of medical devices in the clinical trial stage without authorization.
Medical devices developed by medical institutions shall be used in their own units and shall not be sold to the market.
Twenty-third medical institutions should carefully check the packaging of sterile medical devices before using them. If the packaging of direct contact with medical devices is damaged, it shall be stopped and disposed of in accordance with relevant regulations.
The special equipment used by medical institutions and the measuring instruments listed in the national compulsory verification catalogue shall be used only after passing the verification by the verification institution designated by the administrative department of quality and technical supervision.
Twenty-fourth medical institutions should establish a record of the use of implantable medical devices. The record contents include:
(a) the patient's name, contact address and telephone number;
(two) the date of operation and the name of the surgeon;
(3) Product name, specification (model), manufacturer's name, production batch number (factory number or serial number) and production date;
(four) suppliers, purchase date, contact address and telephone number of suppliers.
The use records of implantable medical devices shall be kept permanently.
Twenty-fifth medical institutions shall implement the provisions of the competent price department of the State Council and the provincial people's government on drug prices. For drugs subject to government pricing, government guidance and government price intervention measures, the price shall not be raised without authorization in any form. Where drugs should be purchased by tender according to law, they should be purchased by tender according to law to reduce the price of drugs. Prohibit profiteering and price fraud that harm the interests of patients.
Medical institutions shall implement a price publicity and inquiry system for drugs and medical devices used by patients, and truthfully provide patients with the price list of drugs and medical devices used.
Twenty-sixth medical institutions shall, in accordance with the relevant provisions of the state, follow up and observe the quality, efficacy and response of drugs and medical devices used by their own units. When discovering adverse reactions that may be related to drugs or devices, it shall promptly report to the food and drug supervision and administration department, the health administrative department or the family planning administrative department of the provincial people's government.
Twenty-seventh in violation of the provisions of the second paragraph of article sixth and the provisions of article seventh, the local food and drug supervision and management department shall order it to make corrections within a time limit; Overdue reform, punishable by a fine of 200 yuan +0000 yuan.
Twenty-eighth in violation of the provisions of article tenth and article twenty-first, the local food and drug supervision and management department shall order it to make corrections, and impose a fine of more than 3000 yuan in 500 yuan.
Twenty-ninth in violation of the provisions of article eleventh of these measures, the local food and drug supervision and management department shall order it to make corrections and impose a fine of more than 2000 yuan and less than 20 thousand yuan.
Article 30 Whoever, in violation of the provisions of Article 14 of these Measures, entrusts other units to produce preparations of medical institutions without the approval of the food and drug supervision and administration department of the provincial people's government shall be supervised by the local food and drug supervision and administration department to destroy the illegal preparations and be fined between 2,000 yuan and 20,000 yuan.
Thirty-first in violation of the provisions of article fifteenth of these measures, the local food and drug supervision and management department shall order it to make corrections, and impose a fine of more than 1000 yuan 10000 yuan.
Article 32 Anyone who violates the provisions of the second and third paragraphs of Article 16 of these Measures and fails to report to the local food and drug supervision and administration department in time shall be given a warning by the local food and drug supervision and administration department and be fined more than 200 yuan 1000 yuan.
Thirty-third in violation of the provisions of article seventeenth of these measures, the local food and drug supervision and management department shall order it to make corrections, and impose a fine of more than 5,000 yuan in 500 yuan.
Thirty-fourth in violation of the provisions of these measures, medical institutions to buy or use medical devices that do not meet the registration standards, the local food and drug supervision and management departments to supervise the destruction, and impose a fine of more than 2000 yuan in 200 yuan.
Thirty-fifth other acts in violation of the provisions of these measures, laws and regulations, from its provisions.
Article 36 If the staff of the food and drug supervision and administration department and other administrative departments abuse their powers, engage in malpractices for selfish ends or neglect their duties in the supervision and management of the use of drugs and medical devices in medical institutions, they shall be given administrative sanctions by their units or the competent department at a higher level according to law; Anyone suspected of committing a crime shall be transferred to judicial organs for investigation according to law.
Article 37 These Measures shall come into force as of February 6, 2006.