Article 1 These Regulations are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and other relevant laws and administrative regulations, combined with the actual situation of this province, in order to standardize drug use, ensure the safety, effectiveness and rationality of human drug use, and safeguard the life and health rights and other legitimate rights and interests of drug recipients.
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 registered and established according to law and drug addicts engaged in disease prevention, health care, drug rehabilitation and other activities.
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 should focus on people's health, follow the principles of safety, effectiveness, science, rationality, economy and convenience, and abide by laws, regulations, rules, standards and norms to ensure the truthfulness, accuracy, completeness and traceability of information.
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 department of the provincial people's government and the department in charge of drug supervision and administration of the people's government of a city or county divided into districts (hereinafter referred to as the drug supervision and administration department) shall be responsible for the supervision and administration of the quality and safety of drug use within their respective administrative areas.
The health department of the people's government at or above the county level shall be responsible for the supervision and administration of pharmaceutical affairs in medical institutions within their respective administrative areas.
Market supervision and management, medical security and other departments shall be responsible for the supervision and management of 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 shall purchase drugs from drug marketing license holders or enterprises with corresponding drug production and business qualifications, except for purchasing Chinese herbal medicines that are not subject to examination and approval management.
Article 9 When purchasing drugs, drug users shall establish and implement the system of incoming inspection and acceptance, verify and verify the supplier's marks such as Drug Production License or Drug Business License, Business License, Power of Attorney and Drug Qualification Certificate, and have a true and complete record of incoming inspection and acceptance. Electronic materials and paper materials have the same effect.
Purchase acceptance records mainly include common name, dosage form, specification, approval number, production batch number, validity period, marketing license holder, manufacturer, supplier, purchase quantity, purchase price, purchase date, acceptance conclusion and inspector's signature.
The storage period of the purchase acceptance record and the relevant information kept 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 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 enterprises that never have the corresponding qualifications for drug production and operation;
(3) illegally purchasing and using preparations prepared by other medical institutions;
(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) Altering or substituting drugs listed in the prescription without authorization;
(2) Violating the incompatibility or over-dosing, and not corrected or re-signed by the prescriber;
(three) direct contact with tablets, capsules and direct oral Chinese herbal pieces and other unpackaged drugs;
(four) other acts prohibited by laws and regulations.
Article 20 Drug users shall be equipped with pharmacists or other pharmaceutical technicians who have obtained qualifications according to law, and shall be responsible for drug management, prescription review and allocation and rational drug use guidance of their own units.
Medical institutions above the second level shall be equipped with clinical pharmacists. Clinical pharmacists should perform duties such as prescription review, drug monitoring and evaluation, providing drug consultation, guiding doctors to use drugs rationally, participating in rounds and consultations, and formulating treatment plans.
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;
(two) the use of drugs that obviously exceed the types and quantities needed to treat diseases;
(3) Failing to use drugs according to the instructions for drug use without justifiable reasons;
(four) 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.
Twenty-fourth 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-fifth recipients or their interested parties and users caused by the use of drugs, you can apply to the medical accident identification agency for identification. 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 Pharmacovigilance
Twenty-sixth provincial people's government shall organize drug supervision and management, health and other departments to establish a drug warning system to monitor, identify, evaluate and control adverse reactions in drug use and other adverse reactions related to drug use.
Article 27 The pharmaceutical supervisory and administrative departments and health departments of the people's governments at the provincial level shall set up monitoring posts for adverse drug reactions, carry out active monitoring, research and evaluation of adverse drug reactions after listing, explore and verify drug safety risk signals, and organize experts to participate in drug safety risk assessment.
Twenty-eighth drug addicts should set up or designate institutions and be equipped with full-time (part-time) staff to undertake the work related to drug vigilance in their own units.
Drug users should take the initiative to monitor the quality and efficacy of drugs, and report suspected adverse reactions and other adverse reactions related to drug use in a timely manner in accordance with relevant national and provincial regulations.
Drug users shall cooperate with the drug supervision and administration and the health department in the investigation of suspected adverse drug reactions or group adverse events, and provide the information needed for the investigation.
Chapter V Supervision and Administration
Article 29 The pharmaceutical supervisory and administrative department of the provincial people's government shall formulate quality management standards for drug use, which shall be implemented after being approved by the provincial people's government.
Drug users should abide by the quality management standards for drug use.
Drug supervision and management, health and other departments shall conduct random supervision and assessment of pharmaceutical technicians of drug addicts and announce the assessment.
Credit management shall be implemented for drug addicts and their legal representatives, principal responsible persons, directly responsible persons in charge and other responsible persons, and disciplinary action for dishonesty shall be carried out according to law.
Article 30 Drug users shall regularly check and record the implementation of the quality management standards and drug quality management system for drug use, and report to the local drug supervision and administration department and the health and health department in time if they find quality and safety hazards such as counterfeit and inferior drugs, and the drug supervision and administration department and the health and health department shall handle them according to law.
Drug addicts should organize people who are in direct contact with drugs to carry out health examination every year and establish health records; Health examination shall be undertaken by medical institutions at or above the second level or disease prevention and control institutions.
Persons suffering from infectious diseases and other diseases that may contaminate drugs shall not engage in direct contact with drugs.
Article 31 The pharmaceutical supervisory and administrative departments and other relevant departments shall provide services for users' pharmaceutical quality management, continuing education and professional training of pharmaceutical technicians.
Article 32 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 33 The relevant departments shall promptly investigate the emergencies caused by drug use according to law, and the pharmaceutical supervisory and administrative departments may take administrative compulsory measures to seal up and detain the relevant drugs in advance according to law. After the situation is under control, the relevant departments shall make administrative treatment according to law.
Chapter VI Legal Liability
Thirty-fourth acts in violation of the provisions of this Ordinance, laws and administrative regulations have stipulated legal liability, its provisions shall apply.
Thirty-fifth in violation of the provisions of these regulations, medical institutions use counterfeit drugs and inferior drugs, and shall be dealt with in accordance with the provisions of 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 36 If a drug user, in violation of the provisions of these Regulations, purchases drugs from an enterprise without the corresponding qualification for drug production and operation, or illegally purchases or uses preparations prepared by other medical institutions, the drug supervision and administration department shall order him to make corrections, confiscate the illegally purchased and used drugs or preparations from medical institutions and the illegal income, and impose a fine of not less than two times but not more than ten times the value of the illegally purchased and used drugs or preparations from medical institutions; If the circumstances are serious, a fine of more than ten times and less than thirty times the value of the goods shall be imposed, and the license issuing organ shall revoke its practice license according to law; If the value of the goods is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
Thirty-seventh in violation of the provisions of this Ordinance, drug users have one of the following acts, the drug supervision and administration department shall order it to make corrections and give 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 five thousand yuan and twenty thousand yuan;
(two) failing to keep the record of purchase acceptance in accordance with the provisions, and impose a fine of not less than three thousand yuan but not more than ten 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 3000 yuan 1 10,000 yuan;
(four) failing to organize the personnel who have direct contact with drugs to carry out health examination and establish health records in accordance with the regulations, and impose a fine of not less than 5,000 yuan but not more than 20,000 yuan.
Thirty-eighth in violation of the provisions of this Ordinance, drug users have one of the following acts, the health department shall order them to make corrections and give them a warning; If the circumstances are serious, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed, and a fine of not less than 5,000 yuan but not more than 20,000 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) Altering or substituting drugs listed in the prescription without authorization;
(3) Violating the incompatibility, or over-dosing the medicine without correction or re-signature by the prescriber;
(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 39 If, in violation of the provisions of these Regulations, drug users use medical advertisements or medical care consulting services to promote the application of drugs and preparations in medical institutions, drug advertisements contain false contents, and non-drug advertisements involve drug promotion, the advertising supervision and administration organs shall investigate and deal with them according to law.
Fortieth in violation of the provisions of these regulations, drug users who fail to report suspected adverse drug reactions in accordance with the provisions shall be ordered to make corrections within a time limit and given a warning; If no correction is made within the time limit, a fine of not less than 50 thousand yuan but not more than 500 thousand yuan shall be imposed.
Article 41 Unless otherwise provided for in these Regulations, if a drug user violates the quality control standards for drug use, the drug supervision and administration department and the health department shall, in accordance with the division of responsibilities, order him to make corrections within a time limit and give him a warning; If no correction is made within the time limit, a fine of not less than five thousand yuan but not more than thirty thousand yuan shall be imposed; If the circumstances are serious, a fine of not less than 30 thousand yuan but not more than 100 thousand yuan shall be imposed. The legal representative, principal responsible person, directly responsible person in charge and other responsible personnel shall be confiscated of their income during the illegal act, and a fine of more than 10% and less than 50% shall be imposed.
Forty-second in violation of the provisions of this Ordinance, the staff of the drug supervision and management, health and other relevant departments have one of the following circumstances, and shall be punished according to law; If the case constitutes a crime, criminal responsibility shall be investigated 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.