first

Article 2 The term "drug use" as mentioned in these Regulations refers to the activities of drug addicts to purchase, store, prepare and use drugs for the purpose of prevention, diagnosis, treatment, rehabilitation and health care and regulation of human physiological functions.

Drug addicts as mentioned in these Regulations refer to medical institutions, family planning technical service institutions and other units engaged in disease prevention, health care, drug rehabilitation and other activities registered and established according to law.

The term "recipient" as mentioned in these Regulations refers to the natural person who accepts the drug services provided by drug users and uses the drug for his own use.

Article 3 These Regulations shall apply to the use of drugs and activities related to drug use within the administrative area of this province. These regulations are not applicable to drugs purchased by individuals for their own use and drugs with special provisions in laws and regulations.

Article 4 The use of drugs shall follow the principles of safety, effectiveness, scientific rationality, economy and convenience.

Article 5 The provincial people's government shall strengthen the leadership over the supervision and administration of drug use, improve the supervision and administration mechanism of drug use, and ensure that drug recipients enjoy high-quality drug services.

The people's governments of cities and counties (cities, districts) divided into districts shall take effective measures to coordinate and solve major problems in the supervision and management of drug use, maintain the order of drug use, and encourage and guide scientific and rational drug use.

Article 6 The drug supervision and administration departments at or above the county (city, district) level shall be responsible for the supervision and administration of drug use within their respective administrative areas.

Health, family planning, industry and commerce, price and other administrative departments shall be responsible for the supervision and management related to drug use according to their respective responsibilities.

Seventh drug users should establish and improve the management system of drug quality and drug use.

Drug users shall set up pharmaceutical affairs management organizations in accordance with state regulations to be responsible for the management of drug use in their own units; In accordance with the provisions of the state, there is no need to set up a drug management institution, and a special person should be appointed to be responsible for the management of drug use.

Chapter II Procurement and Storage of Drugs

Article 8 Drug users must purchase drugs from enterprises with corresponding drug production and operation qualifications, except for Chinese herbal medicines that are not subject to the approval number management.

When purchasing drugs, drug users should first verify and verify the supplier's drug production license or drug business license, business license, power of attorney and other valid documents, properly keep the copy stamped with the supplier's original seal, and should verify the drug certificate.

Article 9 When purchasing drugs, drug users must establish and implement a system of incoming inspection and acceptance, and have a true and complete record of purchasing and acceptance.

Purchase acceptance records mainly include common name, dosage form, specification, approval number, production batch number, validity period, manufacturer, supplier, purchase quantity, purchase price, purchase date, acceptance conclusion, inspector's signature, etc.

The storage period of the purchase acceptance record is one year after the expiration of the validity period of the drug; If the validity period of drugs is less than two years, the storage period of purchase acceptance records shall not be less than three years.

Article 10 If the nature of drugs has special requirements for transportation conditions, drug users shall check whether the drugs meet the requirements of transportation conditions and make records. Those that do not meet the requirements of transportation conditions shall be rejected.

Eleventh drug addicts to buy drugs shall not have the following acts:

(1) purchasing fake or inferior medicines;

(2) purchasing drugs from units or individuals that do not have the corresponding qualifications for drug production and business operation;

(3) buying or using preparations prepared by other medical institutions without authorization;

(four) other acts prohibited by laws and regulations.

Twelfth drug users should set up special places and facilities according to the variety, attributes and quantity of drugs, and be equipped with maintenance personnel.

Article 13 Drug addicts should store drugs in different warehouses, zones and stacks according to the nature and category of drugs, and take measures such as temperature control, moisture prevention, light protection, ventilation, insect prevention, rat prevention, fire prevention and pollution prevention.

Where inflammable, explosive, corrosive and other dangerous drugs are stored, warehouses shall be set up for separate storage, and necessary safety measures shall be taken.

Article 14 Where drug addicts set up warehouses to store drugs, they shall implement color-coded management of the warehouses in accordance with the following provisions:

(1) The qualified drug area is green;

(2) The drug inspection and return area is yellow;

(3) The unqualified drug area is red.

Fifteenth drug users should regularly check the drugs in stock, and eliminate the hidden dangers that affect the quality of drugs in time; The expired, contaminated, deteriorated and other unqualified drugs shall be registered and destroyed in accordance with relevant regulations.

Chapter III Drug Configuration and Application

Article 16 drug users must prepare drugs according to prescriptions or doctor's orders, and strictly implement the operating rules for drug preparation to ensure the accuracy of drugs issued.

The processing of Chinese herbal pieces must conform to the processing norms stipulated by the state and the province.

Article 17 The preparation of drugs or the processing of Chinese herbal pieces shall be carried out in a special place set up independently.

Article 18 When preparing drugs, users should regularly clean and disinfect the tools and containers used for disassembling drugs and keep them clean and hygienic. Packaging materials and containers that come into direct contact with drugs shall be kept clean and shall not pollute drugs.

When dispensing drugs, drug users shall indicate the generic name, specifications, usage, dosage, expiration date and precautions of the drugs on the packaging materials and containers of the sub-packaged drugs, and make detailed records, and keep them for at least one year.

Article 19 When dispensing drugs, drug users shall not commit the following acts:

(1) Dispensing drugs in violation of drug taboos or compatibility taboos;

(two) in violation of state regulations, overdose;

(three) direct contact with tablets, capsules and direct oral Chinese herbal pieces and other unpackaged drugs;

(four) other acts prohibited by laws and regulations.

Twentieth medical institutions above the second level should be equipped with clinical pharmacists. ? Clinical pharmacists should perform duties such as participating in rounds and consultations, designing drug administration plans, providing drug consultation, and supervising doctors' rational drug use.

Twenty-first prescriptions or doctor's orders must use the generic name of drugs or the approved name of preparations of medical institutions. The imported drugs specified in the prescription shall be accompanied by Chinese instructions.

Twenty-second drug addicts shall not have the following acts when using drugs:

(a) the application of counterfeit drugs and inferior drugs;

(2) using drugs in violation of drug contraindications or compatibility contraindications;

(three) the use of drugs that obviously exceed the types and quantities needed to treat diseases;

(4) Failing to use drugs according to the instructions for drug use without justifiable reasons;

(five) using non-drugs as drugs to treat diseases;

(six) other acts prohibited by laws and regulations.

Article 23 Drug users shall not use medical advertisements or medical care consulting services to publicize drugs and preparations of medical institutions. ?

The contents of drug advertisements must be true and legal, and the instructions approved by the drug supervision and administration department of the State Council shall prevail, and shall not contain false contents. Non-drug advertisements shall not contain drug-related content.

Article 24 Drug users shall designate specialized agencies or personnel to be responsible for the monitoring and reporting of adverse drug reactions in their own units to prevent the recurrence of adverse drug reactions.

Twenty-fifth recipients or their interested parties have the right to know the prevention, diagnosis, treatment, side effects and prices of drugs used, and have the right to choose drugs with the same or similar curative effects. Drug addicts should respect the rights of drug addicts or their interested parties and fulfill the corresponding obligation of informing.

Twenty-sixth the recipient or its interested parties and users may apply to the medical accident appraisal institution for appraisal of disputes caused by drug use. The medical accident appraisal institution shall accept the application and conduct appraisal according to the procedures stipulated in the Regulations on Handling Medical Accidents.

The appraisal conclusion can be used as evidence to solve drug disputes, and also as evidence for the relevant competent departments to deal with drug addicts and their directly responsible personnel administratively.

Chapter IV Supervision and Inspection

Twenty-seventh provincial drug supervision and management departments shall formulate the "Shandong Province drug use quality management standards", which shall be implemented after the approval of the provincial people's government.

Drug users should abide by the "Shandong Province Drug Use Quality Management Standards".

Article 28 Medical institutions must be equipped with pharmaceutical technicians with legal qualifications. Non-pharmaceutical technicians in medical institutions may not directly engage in pharmaceutical technical work.

Non-pharmaceutical technicians who are directly engaged in pharmaceutical technical work among other drug addicts shall pass the examination by the municipal drug supervision and administration department with districts.

Twenty-ninth drug addicts should organize people who are in direct contact with drugs to carry out health checks every year and establish health records; The health examination shall be undertaken by a medical institution at or above the second level designated by the local drug supervision and administration department or a disease prevention and control institution, and shall be supervised and implemented by the drug supervision and administration department.

Persons suffering from mental illness, infectious diseases and other diseases that may contaminate drugs shall not engage in direct contact with drugs.

Thirtieth pharmaceutical supervisory and administrative departments and other relevant administrative departments shall provide services for users' drug quality management, continuing education and professional training of pharmaceutical technicians.

Article 31 pharmaceutical supervisory and administrative departments shall supervise and inspect the use of drugs by drug users according to law, and may conduct spot checks on the quality of drugs when necessary, and drug users shall not refuse or conceal them.

Sampling inspection shall be carried out in accordance with the regulations, and no fees shall be charged.

The provincial drug supervision and administration department shall regularly publish the results of random inspection of drug quality.

Article 32 The relevant administrative departments shall promptly investigate the emergencies caused by drug use in accordance with the law, and the pharmaceutical supervisory and administrative departments may take emergency measures such as sealing up and detaining related drugs in advance. After the situation is under control, the relevant administrative departments shall make administrative treatment according to law.

Chapter V Legal Liability

Article 33 Where a unit or individual who violates these regulations and fails to obtain the legal qualification for practicing medicine in accordance with relevant laws and administrative regulations uses drugs, the pharmaceutical supervisory and administrative department shall order it to make corrections, confiscate the illegally used drugs and illegal income, and impose a fine of not less than two times but not more than five times the value of the illegally used drugs.

Article 34 The use of counterfeit and inferior drugs by medical institutions shall be handled in accordance with the Drug Administration Law of People's Republic of China (PRC) and its implementing regulations. Other drug addicts who use counterfeit drugs and inferior drugs shall be punished by the drug supervision and administration department according to the types and extent of administrative punishment for using counterfeit drugs and inferior drugs in medical institutions; If a crime is constituted, criminal responsibility shall be investigated according to law.

Article 35 Where a drug user, in violation of the provisions of these Regulations, purchases drugs from units or individuals that do not have the corresponding qualifications for drug production and operation, or purchases or uses preparations prepared by other medical institutions without authorization, the drug supervision and administration department shall order it to make corrections and confiscate the drugs or preparations prepared by medical institutions that have been illegally purchased or used without authorization; Illegal income, confiscate the illegal income, and impose a fine of more than two times and less than five times the value of drugs or preparations in medical institutions; If the circumstances are serious, the license issuing organ shall revoke its practice license.

Thirty-sixth drug addicts have one of the following acts, the drug supervision and administration department shall order them to make corrections and give them a warning; If the circumstances are serious, a fine shall be imposed in accordance with the following provisions:

(a) the purchase of drugs, there is no true and complete record of purchase acceptance, punishable by a fine of one thousand yuan and five thousand yuan;

(two) failing to keep the record of purchase acceptance in accordance with the provisions, and impose a fine of not less than one thousand yuan but not more than three thousand yuan;

(three) direct contact with tablets, capsules and other unpackaged drugs or direct use of Chinese herbal pieces, punishable by a fine of more than 500 yuan 1000 yuan; ?

(four) the use of non drugs as drugs to treat diseases, punishable by more than 3000 yuan 1 10 thousand yuan fine;

(5) arranging personnel who do not have legal qualifications or have not passed the examination to directly engage in pharmaceutical technical work, and imposing a fine of not less than 1,000 yuan but not more than 5,000 yuan;

(six) failing to organize the health examination and establish health records for the personnel who have direct contact with drugs in accordance with the regulations, and imposing a fine of 1000 yuan but not more than 5,000 yuan;

(seven) arranging for patients with mental illness, infectious diseases and other diseases that may contaminate drugs to contact drugs directly, and imposing a fine of not less than 1,000 yuan but not more than 5,000 yuan.

Thirty-seventh drug addicts have one of the following acts, and administrative punishment has been stipulated by laws and administrative regulations, which shall be implemented in accordance with the provisions; If there are no provisions in laws and administrative regulations, the health administrative department shall order it to make corrections and give a warning; If the circumstances are serious, a fine of not less than five thousand yuan but not more than ten thousand yuan shall be imposed, and a fine of not less than one thousand yuan but not more than five thousand yuan shall be imposed on the persons directly responsible:

(1) Failing to use the generic name of the drug or the approved name of the preparation of the medical institution when prescribing or issuing the doctor's advice;

(2) blending or applying drugs in violation of drug contraindications or compatibility contraindications;

(three) in violation of state regulations, overdose;

(four) the use of drugs that obviously exceed the types and quantities needed to treat diseases;

(5) Failing to use drugs according to the instructions for drug use without justifiable reasons.

Article 38 Drug users use medical advertisements or medical care consulting services to promote the application of drugs and preparations in medical institutions. If drug advertisements contain false contents and non-drug advertisements involve drug promotion, the advertising supervision and management organs shall investigate and deal with them according to law.

Thirty-ninth drug users who violate the "Shandong Province Drug Use Quality Management Standards" shall be ordered by the drug supervision and administration department to make corrections and given a warning; If the circumstances are serious, a fine of not less than one thousand yuan but not more than five thousand yuan shall be imposed.

Article 40 The staff of the pharmaceutical supervisory and administrative department and other relevant administrative departments shall be given administrative sanctions according to law if they are under any of the following circumstances: if the case constitutes a crime, they shall be investigated for criminal responsibility according to law:

(1) recommending the use of drugs to drug addicts by taking advantage of their authority for personal benefit;

(two) in violation of the provisions of the law to conduct random inspection of drug quality;

(three) failing to perform the duties of supervision and inspection or failing to investigate and deal with illegal acts;

(four) other dereliction of duty, abuse of power, favoritism.

Chapter VI Supplementary Provisions

Article 41 These Regulations shall come into force as of March 6, 2007.