Article 1 In order to strengthen the supervision and management of drug use quality and ensure the safety and effectiveness of public drug use, these Provisions are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC), the Regulations on Drug Administration of Hubei Province and other laws and regulations, combined with the actual situation of this province.

Article 2 These Provisions shall apply to the quality supervision and management of drugs purchased, accepted, stored, maintained and prepared by drug users within the administrative area of this province.

The management of narcotic drugs, toxic drugs for medical use, radioactive drugs and other special drugs shall be implemented in accordance with the relevant provisions of the state.

Article 3 Drug addicts mentioned in these Provisions refer to medical institutions, family planning technical service institutions and units engaged in disease prevention, rehabilitation, health care, drug rehabilitation and other activities registered and established according to law.

Article 4 The people's governments at or above the county level shall strengthen their leadership in the supervision and management of drug use quality within their respective administrative areas, clarify the supervision responsibilities, improve the supervision system, increase public investment, and give key support to the supervision and management of drug use quality in rural and poverty-stricken areas.

The pharmaceutical supervisory and administrative departments of the people's governments at or above the county level shall be responsible for the supervision and administration of the quality of drug use within their respective administrative areas.

The relevant departments and units of the people's governments at or above the county level, such as health, population and family planning, public security, justice, industry and commerce, and civil affairs, shall, according to their respective functions and duties, do a good job in supervision and management related to the quality of drug use.

The people's governments at the township level shall, according to the needs, assist the relevant departments of the people's governments at or above the county level to do a good job in the supervision and management of the quality of drug use within their respective administrative areas.

Article 5 Drug users shall strictly abide by the laws, regulations and rules related to drug administration, establish and improve the quality management system for drug use, and be responsible for the quality of drugs used.

Article 6 Encourage and support units and individuals to report and complain about acts that affect the quality of drug use. After receiving reports and complaints, the relevant departments shall promptly investigate and deal with them; Do not belong to the responsibilities of the department, it should be handed over to the relevant departments in a timely manner.

Chapter II Drug Administration Institutions and Personnel

Article 7 A medical institution shall set up a drug administration institution in accordance with the relevant provisions of the state to be responsible for the drug quality management of its own unit.

The establishment of pharmaceutical administration institutions for drug users other than medical institutions shall be implemented with reference to the relevant provisions of medical institutions.

Eighth township hospitals should be responsible for pharmaceutical affairs by pharmaceutical professional and technical personnel; Clinics, health centers, village clinics, medical offices, health centers, health stations and community health service stations shall be equipped with personnel trained by the pharmaceutical supervisory and administrative department or the competent health department of the people's government at or above the county level. Chinese medicine clinics and ethnic medicine clinics shall be responsible for pharmaceutical affairs by professional and technical personnel of Chinese medicine and ethnic medicine respectively.

The person in charge of the pharmaceutical administration institution of the family planning technical service institution at or above the county level shall have the professional and technical title of pharmacy at or above the primary level; The person in charge of the pharmaceutical administration institution of the township family planning technical service institution shall be a person trained by the pharmaceutical supervisory and administrative department of the people's government at or above the county level.

The person in charge of the pharmaceutical affairs management institution of a drug-using unit engaged in disease prevention, rehabilitation and health care, drug rehabilitation and other activities shall be a pharmaceutical professional and technical personnel.

Article 9 Drug-using units shall organize the personnel who have direct contact with drugs to have annual health check-ups and establish health records.

Persons suffering from infectious diseases or other diseases that may contaminate drugs shall not engage in direct contact with drugs.

Article 10 Drug users shall formulate training plans, conduct relevant laws, regulations and professional knowledge training for personnel directly engaged in drug procurement, acceptance, storage, maintenance and deployment, and establish training files.

Chapter III Drug Purchase and Acceptance

Article 11 Drug-using units shall purchase drugs from enterprises qualified for drug production and trading, and the drugs shall be purchased by specialized agencies in accordance with regulations.

Drug users who need to import drugs shall do so in accordance with the relevant provisions of the state.

Article 12 When purchasing drugs, drug users should check the drug production license or drug business license and business license of the supplier, the approval documents of the drugs sold and other related materials, and verify the original authorization certificate and ID card held by the sales staff.

Drug users shall properly keep a copy of the information mentioned in the preceding paragraph with the original seal of the supplier affixed to the drugs purchased for the first time, and the retention period shall not be less than five years.

Article 13 When purchasing drugs, drug users shall ask for and keep the legal bills of the supplier, establish purchase records, and ensure that the bills, accounts and drugs are consistent.

Legal bills include tax bills and lists. The list must include the name of supplier, generic name of drug, manufacturer, batch number, quantity and price. The custody period of legal bills shall not be less than three years.

Article 14 Drug users shall establish a drug purchase acceptance system, and the purchased drugs shall be accepted batch by batch, and the drug acceptance records shall be true and complete.

Medical institutions shall abide by the provisions of the preceding paragraph when accepting donated drugs and allocating emergency drugs from other medical institutions.

Article 15 The drug acceptance record shall include the name of the supplier, the generic name of the drug, the manufacturer, specifications, dosage form, batch number, production date, expiration date, approval number, quantity, price, purchase date, acceptance date and acceptance conclusion.

Acceptance records shall be kept for one year after the expiration of the validity period of drugs, but the storage time shall not be less than three years.

Article 16 When purchasing vaccines, biological products, blood products and other drugs that need to be transported in cold chain, drug users should check whether the transportation conditions meet the requirements and make records. Those that do not meet the requirements of transportation conditions shall be rejected.

Article 17 Drug users shall, in accordance with the requirements of the pharmaceutical supervisory and administrative departments of the people's governments at or above the county level, implement electronic management of drug purchase and sale records.

Chapter IV Storage and Maintenance of Drugs

Article 18 Drug users shall store drugs according to the storage requirements indicated in the drug instructions.

Drug addicts need to temporarily store drugs in emergency rooms, ward nurse stations and other places, and should be equipped with counters that meet the conditions for drug storage; Drugs with special storage requirements shall be equipped with corresponding equipment.

Article 19 Drug users should set up pharmacies (warehouses) suitable for the scope of diagnosis and treatment and the scale of drug use, which are separated from the diagnosis and treatment areas, and set up normal temperature warehouses, cold storage warehouses and cold storage warehouses (cabinets) according to the requirements of drug storage.

Twentieth drug users should be equipped with the following corresponding pharmacy (library) facilities and equipment according to the needs of drug storage and management:

(a) Facilities such as drug racks to keep drugs at a proper distance from the ground and walls;

(2) facilities such as mildew prevention, rat prevention, insect prevention, dust prevention, moisture prevention and pollution prevention;

(3) Refrigeration, light protection and ventilation equipment;

(4) Equipment for detecting and adjusting temperature and humidity;

(five) lines, equipment and lighting facilities that meet the requirements of safe electricity use;

(six) other facilities and equipment that meet the needs of drug storage.

Twenty-first pharmacies (warehouses) should strictly divide the special areas such as drug areas to be tested, qualified drug areas and unqualified drug areas, and set up obvious signs.

Drug users shall, according to the nature and category of drugs, store them in warehouses, districts and stacks. Drugs and non-drugs, internal medicine and external medicine are stored separately; Chinese herbal pieces, Chinese patent medicines and chemicals are stored separately and classified; Easy-to-smell drugs are stored separately and sealed; Expired, deteriorated, polluted and other unqualified drugs shall be stored in the unqualified drug area.

Article 22 Drug users shall formulate and implement a drug storage and maintenance management system, assign drug maintenance personnel, take the following measures to inspect and maintain the drugs in stock, and keep inspection and maintenance records:

(a) regularly check the drugs in stock, and take timely measures to deal with the possible quality problems of drugs;

(two) regularly monitor the temperature and humidity of the pharmacy (library), and take timely control measures when it is found that the temperature and humidity are beyond the prescribed range;

(three) to strengthen the management of the expiration date of drugs, and set up obvious signs for drugs near the expiration date;

(four) regular inspection and maintenance of related facilities and equipment.

Twenty-third drug addicts should establish a drug transfer review system. When distributing drugs, the generic name, manufacturer, batch number, specification, expiration date, quantity and date of the drugs shall be recorded.

Chapter V Drug Allocation

Twenty-fourth registered medical practitioners and assistant medical practitioners (hereinafter referred to as doctors) shall make prescriptions in accordance with the relevant provisions of prescription management.

The examination and deployment of prescriptions shall be carried out by pharmaceutical professional and technical personnel (hereinafter referred to as pharmacists) who have obtained the qualifications for pharmaceutical professional and technical positions.

Twenty-fifth pharmacists in the examination and approval of the prescription, that prescription drugs are not suitable, it should inform the prescriber, asking him to confirm or reissue the prescription; If it is found that the drug use is seriously unreasonable or wrong, it shall refuse to allocate it, inform the prescriber in time, record it and report it in accordance with the relevant provisions of the state.

Article 26 The tools, facilities, packages and places used by drug users to prepare drugs shall meet the requirements of drug hygiene and corresponding preparations.

Article 27 Drug users shall establish a management system for disassembling and dispensing small packages of drugs. When disassembling and dispensing drugs, records of disassembling and dispensing should be made, and at least one minimum package with the same batch number should be kept.

Twenty-eighth pharmacists shall sign or seal the prescription after completing the examination and preparation of the prescription; When dispensing drugs, corresponding instructions and medication instructions should be made according to the drug instructions or prescriptions.

Twenty-ninth preparations prepared by medical institutions are limited to their own use. Without the approval of the pharmaceutical supervisory and administrative department of the state or provincial people's government, medical institutions shall not use preparations prepared by other medical institutions, and shall not provide preparations prepared by their own units to other medical institutions.

Chapter VI Supervision and Administration

Article 30 The pharmaceutical supervisory and administrative departments of the people's governments at or above the county level shall strengthen the supervision and inspection of the purchase, acceptance, storage, maintenance and deployment of drugs by drug users within their respective administrative areas, focusing on the supervision and inspection of the use quality of drugs listed in the national essential drugs list and the provincial non-directory drugs list.

The supervision and inspection situation and treatment results shall be recorded in writing, signed by the supervision and inspection personnel, and fed back to the inspected unit. If it is found in the inspection that there are circumstances that need to be handled by other departments, it shall be transferred in time.

Article 31 The pharmaceutical supervisory and administrative departments of the people's governments at or above the county level shall strengthen the sampling inspection of drug quality of drug addicts. The sampling results are regularly announced to the public by the provincial drug supervision and administration department.

Drug users who have objections to the results of sampling inspection of drug quality may apply for re-inspection in accordance with relevant regulations, and the re-inspection procedures shall be implemented in accordance with relevant regulations.

Article 32 The pharmaceutical supervisory and administrative department of the people's government at or above the county level shall, according to the actual situation, establish a credit file for drug quality management of drug users. Archives shall record the results of daily supervision and inspection, bad credit records, reports and complaints, and the investigation and punishment of illegal acts, and make them public according to law.

The pharmaceutical supervisory and administrative departments of the people's governments at or above the county level may, according to the credit files of drug quality management of drug users, determine a number of units to carry out key supervision and inspection.

Thirty-third drug users should regularly check the purchase, acceptance, storage, maintenance and deployment of drugs in their own units, and make records. When the pharmaceutical supervisory and administrative department conducts supervision and inspection, drug users shall truthfully provide articles, records, vouchers and other materials related to the inspected articles, and shall not obstruct or refuse.

Article 34 Drug users should strengthen drug quality control. If counterfeit or inferior drugs are found, they shall immediately stop using them, seal them up on the spot, keep them properly, and report to the pharmaceutical supervisory and administrative department of the local people's government at or above the county level, and shall not be disposed of without authorization.

Drug users should immediately stop using drugs when they find that there are hidden dangers in the quality of drugs, and report to the pharmaceutical supervisory and administrative departments of local people's governments at or above the county level. Where a drug needs to be recalled, the drug-using entity shall assist the drug-producing enterprise in fulfilling the recall obligation.

Thirty-fifth drug users should establish a system for monitoring and reporting adverse drug reactions, implement the personnel responsible for monitoring and reporting adverse drug reactions, and fulfill their obligations of monitoring and reporting adverse drug reactions according to law.

Chapter VII Legal Liability

Thirty-sixth in violation of these provisions, laws and regulations have penalties, from its provisions.

Article 37 A drug user who commits one of the following acts shall be given a warning by the pharmaceutical supervisory and administrative department of the people's government at or above the county level and ordered to make corrections within a time limit; If no correction is made within the time limit, a fine of two thousand yuan or more and twenty thousand yuan or less shall be imposed; If the circumstances are serious, the relevant department shall revoke its practice license according to law:

(1) arranging persons suffering from infectious diseases or other diseases that may pollute drugs to engage in direct contact with drugs in violation of regulations;

(2) Failing to implement the system of incoming goods acceptance, obtaining legal bills and establishing a true and complete acceptance record;

(3) Failing to store or keep drugs according to regulations;

(four) failing to keep records of drug procurement, acceptance, storage, maintenance and deployment in accordance with the provisions.

Article 38 Where the pharmaceutical supervisory and administrative department of the people's government at or above the county level and other relevant departments and their staff neglect their duties in the supervision and management of drug use quality, they shall be given administrative sanctions by their units, higher authorities or supervisory organs according to law; If a crime is constituted, criminal responsibility shall be investigated according to law.

Chapter VIII Supplementary Provisions

Article 39 These Provisions shall come into force as of August 1 day, 2065.