Chapter 1 General Provisions

Article 1 is to strengthen the supervision and management of drug use quality and ensure the safety and effectiveness of public drug use. According to the "Drug Administration Law of the People's Republic of China", The "Hubei Provincial Drug Administration Regulations" and other laws and regulations are formulated based on the actual conditions of the province.

Article 2 These regulations apply to the quality supervision and management of drug purchase, acceptance, storage, maintenance and deployment of drug users within the administrative region of this province.

The management of special drugs such as anesthetic drugs, medical toxic drugs and radioactive drugs shall be implemented in accordance with relevant national regulations.

Article 3: Drug-using units as mentioned in these regulations refer to medical institutions, family planning technical service institutions, and units engaged in disease prevention, rehabilitation and health care, drug detoxification and other activities that are registered in accordance with the law and use drugs.

Article 4 People’s governments at or above the county level shall strengthen leadership in the supervision and management of drug use quality within their own administrative regions, clarify regulatory responsibilities, improve the regulatory system, increase public investment, and provide medical services to rural and poverty-stricken areas. Provide key support to the supervision and management of drug use quality.

The drug regulatory departments of the people’s governments at or above the county level are responsible for the supervision and management of the quality of drug use within their respective administrative regions.

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

The people's government at the township level shall assist the relevant departments of the people's government at or above the county level as required to supervise and manage the quality of drug use within its own administrative region.

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

Article 6: Encourage and support units and individuals to report and complain about behaviors that affect the quality of drug use. After receiving reports and complaints, relevant departments should promptly investigate and deal with them; if they do not fall within the responsibilities of the department, they should promptly transfer them to the relevant departments for processing.

Chapter 2 Pharmaceutical Management Organizations and Personnel

Article 7 Medical institutions shall set up pharmaceutical management organizations in accordance with relevant national regulations to be responsible for the unit’s drug quality management work.

The establishment of pharmaceutical management agencies of other drug-using units other than medical institutions shall be implemented with reference to the relevant regulations of medical institutions.

Article 8 Township health centers shall have pharmacy professional and technical personnel responsible for pharmaceutical affairs; clinics, health clinics, village clinics, infirmaries, health care clinics, health stations and community health service stations shall have managers Personnel trained by the drug regulatory department or the health authority of the people's government at or above the county level shall be responsible for pharmaceutical work; traditional Chinese medicine clinics and ethnic medicine clinics shall have professional and technical personnel of traditional Chinese medicine and ethnic medicine respectively responsible for pharmaceutical work.

The person in charge of the pharmaceutical management agency of the family planning technical service institution at or above the county level shall have a junior or above professional technical title in pharmacy; the person in charge of the pharmaceutical management institution of the township family planning technical service institution shall be appointed by the county-level The above-mentioned personnel trained by the drug regulatory departments of the people's governments shall serve.

The person in charge of the pharmaceutical management agency of a drug-using unit engaged in activities such as disease prevention, rehabilitation and health care, drug detoxification, etc. shall be a pharmaceutical professional and technical personnel.

Article 9 Drug-using units shall organize health examinations for personnel who are in direct contact with drugs every year and establish health files.

Personnel suffering from infectious diseases or other diseases that may contaminate drugs are not allowed to engage in work with direct contact with drugs.

Article 10 Drug user units shall formulate training plans to conduct relevant laws, regulations and rules and professional knowledge training for personnel directly engaged in drug purchase, acceptance, storage, maintenance and deployment, and establish Training files.

Chapter 3 Drug Purchase and Acceptance

Article 11 Drug users shall purchase drugs from enterprises with drug production and operation qualifications, and shall be unified by specialized agencies in accordance with regulations purchase.

If a drug user unit needs to import drugs, it must do so in accordance with relevant national regulations.

Article 12 When a drug user purchases drugs, it shall check the supplier's "Drug Production License" or "Drug Distribution License" and "Business License", as well as the approval documents for the drugs sold. and other relevant materials, and verify the original authorization certificate and original ID card held by the salesperson.

The drug user unit shall properly keep copies of the materials mentioned in the preceding paragraph with the original seal of the supplier of the drug purchased for the first time, and the storage period shall not be less than five years.

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

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

Article 14: Drug user units shall establish a drug purchase inspection and acceptance system. Purchased drugs shall be inspected batch by batch, and drug acceptance records shall be true and complete.

Medical institutions shall comply with the provisions of the preceding paragraph when accepting donated drugs and transferring emergency drugs from other medical institutions.

Article 15 Drug acceptance records shall include the name of the supplier, the common name of the drug, manufacturer, specification, dosage form, batch number, production date, validity period, approval number, quantity, price, and purchase date , acceptance date and acceptance conclusion, etc.

The acceptance record shall be kept until one year after the expiration of the drug's validity period, but the retention period shall not be less than three years.

Article 16 When a drug user unit purchases vaccines, biological products, blood products and other drugs that need to maintain cold chain transportation conditions, it shall check whether the transportation conditions meet the requirements and keep records; If the conditions require it, acceptance shall be refused.

Article 17 Drug users shall implement electronic management of drug purchase and sale records in accordance with the requirements of the drug regulatory department of the people's government at or above the county level.

Chapter 4 Drug Storage and Maintenance

Article 18 Drug users shall store drugs in accordance with the storage requirements indicated in the drug instructions.

If a drug user unit needs to temporarily store drugs in emergency rooms, ward nurse stations and other places, it should be equipped with special counters that meet the drug storage conditions; for drugs with special storage requirements, it should be equipped with corresponding equipment.

Article 19: Drug-using units shall set up pharmacies (warehouses) that are suitable for the scope of diagnosis and treatment and the scale of drug use, and that are separate from the diagnosis and treatment areas and treatment areas, and shall set up normal temperature warehouses, cool warehouses, and warehouses according to drug storage requirements. Cold storage (cabinet).

Article 20: Drug-using units shall be equipped with the following corresponding pharmacy (warehouse) facilities and equipment based on drug storage and management needs:

(1) Keep drugs away from the floor and walls Medicine shelves and other facilities with appropriate distance between surfaces;

(2) Mildew-proof, rodent-proof, insect-proof, dust-proof, moisture-proof, pollution-proof and other facilities;

(3) Refrigeration, light-proofing, and ventilation equipment;

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

(5) Lines, equipment, and lighting facilities that meet the requirements for safe electricity use;

(6) Other facilities and equipment that meet the needs of drug storage.

Article 21 Pharmacies (warehouses) should strictly divide special areas such as the area for untested drugs, the area for qualified drugs, and the area for unqualified drugs, and set up obvious signs.

Drug users should separate warehouses, partitions, and stack storage according to the attributes and categories of drugs. Drugs and non-drugs, internal medicines and external medicines should be stored separately; Chinese herbal medicine pieces, Chinese patent medicines, and chemical drugs should be stored separately and classified; drugs that are prone to odor transfer should be stored separately and airtight; expired, spoiled, contaminated, and other unqualified drugs should be stored in the unqualified drug category. district.

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

(1) Regularly inspect the drugs in stock, and take timely measures to deal with them if they find that they may have quality problems;

(2) Regularly check the temperature and humidity of the pharmacy (storage) Monitor and take timely control measures when it is found that the temperature and humidity exceed the specified range;

(3) Strengthen the management of drug validity period, and set clear signs for drugs near the validity period;

(4) Regularly inspect and maintain relevant facilities and equipment.

Article 23: Drug user units shall establish a drug delivery review system. When distributing drugs, the generic name, manufacturer, production batch number, specifications, validity period, quantity, date, etc. of the drug should be recorded.

Chapter 5 Drug Dispensing

Article 24 Registered practicing physicians and practicing assistant physicians (hereinafter collectively referred to as physicians) shall issue prescriptions in accordance with the relevant regulations on prescription management.

The review and dispensing 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.

Article 25 When a pharmacist reviews a prescription and believes that the prescribed medication is inappropriate, he or she shall inform the prescribing physician and ask him or her to confirm or reissue the prescription; if a pharmacist finds that the medication is seriously unreasonable or wrong, he or she shall If dispensing is refused, the prescribing physician shall be informed in a timely manner, and shall be recorded and reported in accordance with relevant national regulations.

Article 26 The tools, facilities, packaging supplies and areas used for drug compounding by drug users shall comply with drug hygiene requirements and corresponding compounding requirements.

Article 27 Drug user units shall establish a management system for dismantling and distributing drugs in minimum packages. When dismantling and distributing drugs, they shall keep records of disassembly and save at least one minimum package with the same batch number.

Article 28 After completing the prescription review and preparation, the pharmacist shall sign or seal the prescription; when dispensing the medicine, he shall provide corresponding explanations and medication instructions in accordance with the drug instructions or the prescription doctor's instructions.

Article 29 Preparations prepared by medical institutions are limited to the use of the unit. Without the approval of the drug regulatory department of the national or provincial people's government, medical institutions shall not use preparations prepared by other medical institutions, and shall not provide preparations prepared by the unit to other medical institutions.

Chapter 6 Supervision and Management

Article 30 The drug supervision and administration department of the people’s government at or above the county level shall strengthen the supervision of drug purchase, acceptance, storage, and Supervision and inspection of maintenance and deployment, etc., and key supervision and inspection on the use quality of drugs included in the National Essential Drug List and the Provincial Non-list Drug List.

The supervision and inspection status and processing results should be recorded in writing, signed by the supervisory and inspection personnel and then fed back to the inspected unit. If any situation is discovered during the inspection that requires handling by other departments, it should be transferred in a timely manner.

Article 31 The drug regulatory departments of the people’s governments at or above the county level shall strengthen random inspections of drug quality in drug-using units. The results of random inspections are regularly announced to the public by the provincial drug regulatory department.

If a drug user has objections to the results of drug quality sampling inspections, it may apply for re-inspection in accordance with regulations, and the re-inspection procedures shall be implemented in accordance with relevant regulations.

Article 32 The drug regulatory departments of the people’s governments at or above the county level shall establish drug quality management credit files for drug users based on the actual situation. The files should record the results of daily supervision and inspections, bad credit records, reports and complaints, as well as the investigation and punishment of illegal activities, and disclose them to the public in accordance with the law.

The drug regulatory departments of the people's governments at or above the county level may determine a number of units to conduct key supervision and inspections based on the drug quality management credit files of drug users.

Article 33: Drug user units shall regularly conduct self-examinations on the unit’s drug purchase, acceptance, storage, maintenance, and deployment, and keep records. When the drug regulatory department conducts supervision and inspection, the drug user unit shall truthfully provide items, records, vouchers and other materials related to the items being inspected, and shall not obstruct or refuse.

Article 34 Drug users shall strengthen monitoring of drug quality. If counterfeit or substandard drugs are found, they should immediately stop using them, seal them on site and keep them properly, and report them to the drug regulatory department of the local people's government at or above the county level. They should not handle them without authorization.

When a drug user discovers that a drug has quality hazards, it should immediately stop using it and report it to the drug regulatory department of the local people's government at or above the county level. If a drug needs to be recalled, the drug user unit shall assist the drug manufacturer in fulfilling the recall obligations.

Article 35: Drug user units shall establish an adverse drug reaction monitoring and reporting system, assign personnel to be responsible for adverse drug reaction monitoring and reporting work, and perform adverse drug reaction monitoring and reporting obligations in accordance with the law.

Chapter 7 Legal Responsibilities

Article 36 If any laws or regulations have penalty provisions for violation of these provisions, such provisions shall prevail.

Article 37 If a drug user unit commits any of the following acts, the drug supervision and administration department of the people's government at or above the county level shall give a warning and order it to make corrections within a time limit; if it fails to make corrections within the time limit, it shall be fined not less than 2,000 yuan and 2,000 yuan. A fine of not more than 10,000 yuan; if the circumstances are serious, the relevant department shall revoke the practice license in accordance with the law:

(1) Violating regulations and arranging personnel with infectious diseases or other diseases that may contaminate drugs to engage in direct contact with drugs ;

(2) Failure to implement the purchase acceptance system, request legal bills, and establish true and complete acceptance records as required;

(3) Failure to store and maintain drugs as required;

(4) Failure to keep records of drug purchase, acceptance, storage, maintenance and deployment as required.

Article 38 If the drug regulatory departments of the people’s governments 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, their units or superior agencies, supervisory authorities, etc. The authorities shall impose administrative sanctions in accordance with the law; if a crime is constituted, criminal liability shall be investigated in accordance with the law.

Chapter 8 Supplementary Provisions

Article 39 These regulations will come into effect on August 1, 2012.