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413
50，
412，《》（《》）。
《》，“”《》，，《》（〔2021〕35），2021412，。
，《》《》（〔2021〕35），，。，。
，。，20212021。
Shanxi Province also talked about resolutely implementing the "four most stringent" regulatory requirements, and arranging and deploying in accordance with the National Drug Registration Management and Post-Marketing Regulatory Work Conference and the Provincial Drug Supervision and Party Style and Clean Government Construction Work Conference to prevent risks, ensure safety, and strengthen Supervise, promote development, and effectively guarantee the safety of people's medication.
In addition, judging from the documents issued by Zhejiang, Shanxi, Anhui and other provinces, the focus is on the fundamental orientation of the "four strictest", which also means that this year’s inspections and penalties will be very strict, and retail pharmacies will be severely affected if they violate regulations.
Penalty.
Penalty.
7 types of pharmacies, key inspections
The "Notice" clarified that it is necessary to fully implement the main responsibilities of drug business and use units, strengthen supervision and inspection of key areas, key varieties, and key links, investigate and resolve hidden risks in drug circulation, and urge relevant units to operate and use drugs in accordance with laws and regulations.
According to the "Notice", 7 types of enterprises shall be inspected, specifically as follows:
1.
Pharmaceutical companies that have seriously violated the drug GSP since 2019;
Pharmaceutical companies that have seriously violated the drug GSP since 2019;
2.
Pharmaceutical companies that have repeatedly violated the drug GSP since 2019;
Pharmaceutical companies that have repeatedly violated the drug GSP since 2019;
3.
Drug dealers and users who have been complained and reported many times since 2019;
Drug dealers and users who have been complained and reported many times since 2019;
4.
Since 2019, the operating enterprises and users of unqualified drugs have been spot-checked;
Since 2019, the operating enterprises and users of unqualified drugs have been spot-checked;
5.
Pharmaceutical wholesale enterprises that entrust other enterprises to store and transport drugs (retail chain headquarters) and pharmaceutical wholesale enterprises that accept entrusted storage and transportation services;
Pharmaceutical wholesale enterprises that entrust other enterprises to store and transport drugs (retail chain headquarters) and pharmaceutical wholesale enterprises that accept entrusted storage and transportation services;
6.
Newly established pharmaceutical business enterprises since 2020;
Newly established pharmaceutical business enterprises since 2020;
7.
Other drug dealers and users that need to be inspected.
Other drug dealers and users that need to be inspected.
The key inspection varieties involve 5 categories, which are as follows:
1.
Refrigerated and frozen medicines such as vaccines, human albumin, and human immunoglobulin;
Refrigerated and frozen medicines such as vaccines, human albumin, and human immunoglobulin;
2.
Special drug compound preparations containing ephedrine, tramadol, diphenoxylate, etc.
;
Special drug compound preparations containing ephedrine, tramadol, diphenoxylate, etc.
;
3.
Drugs for the prevention and control of the new crown epidemic;
Drugs for the prevention and control of the new crown epidemic;
4.
Selected varieties in the centralized procurement of national drugs, etc.
;
Selected varieties in the centralized procurement of national drugs, etc.
;
5.
High-value antihypertensive and hypoglycemic drugs, cardiovascular and cerebrovascular drugs, and anti-tumor drugs are included in medical insurance drugs.
High-value antihypertensive and hypoglycemic drugs, cardiovascular and cerebrovascular drugs, and anti-tumor drugs are included in medical insurance drugs.
The inspection started in May, and the pharmacy focused on three major behaviors
The "Notice" talked about three stages: the mobilization and deployment stage (April 2021), the centralized inspection stage (May-October 2021), and the supervision and spot check stage (November-December 2021).
For pharmaceutical retail companies, the key inspection content is to carry out retail inspections focusing on retail pharmacies in urban-rural fringe areas, rural areas, and retail pharmacies around secondary medical institutions.
One is the inspection of drug purchase and sale channels.
Focus on checking the company's drug purchase and sales records, bills, and vouchers, whether there are illegal recycling or participation in illegal recycling of drugs, sales of recycled drugs, and illegal purchase and sale of preparations from medical institutions.
Focus on checking the company's drug purchase and sales records, bills, and vouchers, whether there are illegal recycling or participation in illegal recycling of drugs, sales of recycled drugs, and illegal purchase and sale of preparations from medical institutions.
The second is to check the availability of licensed pharmacists.
According to the "Notice of the State Drug Administration on Regulating the Provision and Use of Licensed Pharmacists in Drug Retail Enterprises" (National Drug Administration and Drug Administration ﹝2020﹞ No.
25) and the Autonomous Region Drug Administration’s "Notice on Issues Concerning the Management of the Distribution and Use of Licensed Pharmacists in Retail Pharmacies" ( Ningyao Jianfa [2020] No.
71) required to check whether retail pharmacies are equipped with licensed pharmacists (or pharmaceutical technicians) as required and whether they are practicing on the job.
According to the "Notice of the State Drug Administration on Regulating the Provision and Use of Licensed Pharmacists in Drug Retail Enterprises" (National Drug Administration and Drug Administration ﹝2020﹞ No.
25) and the Autonomous Region Drug Administration’s "Notice on Issues Concerning the Management of the Distribution and Use of Licensed Pharmacists in Retail Pharmacies" ( Ningyao Jianfa [2020] No.
71) required to check whether retail pharmacies are equipped with licensed pharmacists (or pharmaceutical technicians) as required and whether they are practicing on the job.
The third is the inspection of prescription drug sales.
Carry out a comprehensive inspection of the behavior of not selling prescription drugs in accordance with regulations, focusing on checking whether there is a failure to sell compound preparations containing special drugs, sales of vaccines, narcotic drugs, first-class psychotropic drugs, pharmaceutical precursor chemicals, pregnancy termination drugs, and traditional Chinese medicines.
Recipe granules and other drugs that are banned from retail by the state.
Carry out a comprehensive inspection of the behavior of not selling prescription drugs in accordance with regulations, focusing on checking whether there is a failure to sell compound preparations containing special drugs, sales of vaccines, narcotic drugs, first-class psychotropic drugs, pharmaceutical precursor chemicals, pregnancy termination drugs, and traditional Chinese medicines.
Recipe granules and other drugs that are banned from retail by the state.
In addition, each city should also monitor whether designated drug retail companies comply with the "Notice on Doing a Good Job in Drug Sales Monitoring During the Period of Normalization of the Prevention and Control of the New Coronary Pneumonia Epidemic" (Ning Yao Jianfa [2020] No.
51) and local joint prevention and control of the new crown pneumonia The mechanism requires inspection of the sales monitoring of four types of drugs, including fever, cough, antiviral, and antibacterial.
51) and local joint prevention and control of the new crown pneumonia The mechanism requires inspection of the sales monitoring of four types of drugs, including fever, cough, antiviral, and antibacterial.
Posting documents in many places, pharmacy inspections have started
According to a review, as of now, Jiangsu, Zhejiang, Shanxi, Anhui, Liaoning and other provinces have issued documents clarifying the inspection of retail pharmacies in 2021.
Jiangsu: Regarding the standardization of purchase and sales channels, business processes, and storage conditions, strengthen the supervision of business and use links.
Strengthen the supervision and inspection of pharmacists' on-the-job, prescription drug sales and other links, and increase the supervision of private medical institutions, plastic and cosmetic medical institutions, individual clinics, and maternal and child products specialty stores.
Strengthen the supervision and inspection of pharmacists' on-the-job, prescription drug sales and other links, and increase the supervision of private medical institutions, plastic and cosmetic medical institutions, individual clinics, and maternal and child products specialty stores.
Zhejiang: Unannounced inspections of retail companies are organized and arranged by local organizations; focus on inspections of pharmaceutical retail companies in rural areas of the urban-rural fringe, and pharmaceutical retail companies that carry out online ordering stores and online ordering stores.
The focus of the inspection is the following 11 behaviors:
The focus of the inspection is the following 11 behaviors:
1.
Whether the traceability system of key products (vaccine, special management drugs, blood products, national centralized procurement drugs) is complete;
Whether the traceability system of key products (vaccine, special management drugs, blood products, national centralized procurement drugs) is complete;
2.
Quality risk control involving counterfeit and inferior drugs (business scope, automatic control of drug expiration date, near-effective drug inventory management, etc.
), whether the inspection of drug packaging and properties is performed in strict accordance with the requirements of GSP;
Quality risk control involving counterfeit and inferior drugs (business scope, automatic control of drug expiration date, near-effective drug inventory management, etc.
), whether the inspection of drug packaging and properties is performed in strict accordance with the requirements of GSP;
3.
Whether to provide premises, qualification certificates, bills and other conditions for others to illegally trade drugs; purchase from individuals or units without "Drug Production License" and "Drug Distribution License", enterprises or institutions without "Drug Registration Certificate" Drugs; selling drugs to units or individuals without legal qualifications, knowing or ought to know that others are engaged in unlicensed business and still providing drugs for them;
Whether to provide premises, qualification certificates, bills and other conditions for others to illegally trade drugs; purchase from individuals or units without "Drug Production License" and "Drug Distribution License", enterprises or institutions without "Drug Registration Certificate" Drugs; selling drugs to units or individuals without legal qualifications, knowing or ought to know that others are engaged in unlicensed business and still providing drugs for them;
4.
Whether the person in charge of corporate quality and quality management personnel perform their duties; whether the licensed pharmacist is certified;
Whether the person in charge of corporate quality and quality management personnel perform their duties; whether the licensed pharmacist is certified;
5.
The company's cold chain drug management, whether the drug storage and transportation records are complete and true; whether the drug storage, transportation, and temperature and humidity monitoring are not performed in accordance with regulations; whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time;
The company's cold chain drug management, whether the drug storage and transportation records are complete and true; whether the drug storage, transportation, and temperature and humidity monitoring are not performed in accordance with regulations; whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time;
6.
Whether to falsify the source of drug purchases, fabricate the flow of drug sales, tamper with the computer system, temperature and humidity monitoring system data, conceal the real drug purchase and sale records, bills, vouchers, data, etc.
, the drug purchase and sale records are incomplete, untrue, and business operations cannot be performed Retrospective
Whether to falsify the source of drug purchases, fabricate the flow of drug sales, tamper with the computer system, temperature and humidity monitoring system data, conceal the real drug purchase and sale records, bills, vouchers, data, etc.
, the drug purchase and sale records are incomplete, untrue, and business operations cannot be performed Retrospective
7.
When purchasing and selling drugs, certificates (licenses), tickets (invoices, bills accompanying the goods), accounts (physical accounts, financial accounts), goods (physical drugs), and payments (payments) cannot correspond to each other; the drugs are not stored in the warehouse , Set up off-book accounts, drugs are not included in the enterprise quality management system, use bank personal accounts for business transactions, etc.
;
When purchasing and selling drugs, certificates (licenses), tickets (invoices, bills accompanying the goods), accounts (physical accounts, financial accounts), goods (physical drugs), and payments (payments) cannot correspond to each other; the drugs are not stored in the warehouse , Set up off-book accounts, drugs are not included in the enterprise quality management system, use bank personal accounts for business transactions, etc.
;
8.
Whether the drug is stored in a place other than the approved address; whether the registered address, business method, and business scope are sold without authorization;
Whether the drug is stored in a place other than the approved address; whether the registered address, business method, and business scope are sold without authorization;
9.
Failing to monitor the temperature and humidity of the storage and transportation of drugs in accordance with regulations;
Failing to monitor the temperature and humidity of the storage and transportation of drugs in accordance with regulations;
10.
Retail companies have problems selling prescription drugs and recalling drugs in violation of regulations;
Retail companies have problems selling prescription drugs and recalling drugs in violation of regulations;
11.
Other violations of laws and regulations.
Other violations of laws and regulations.
Shanxi: Pharmaceutical retail companies focus on prescription drugs, Chinese herbal medicines, and cold chain drugs.
Based on compliance inspections, they focus on purchasing drugs and recycling drugs through illegal channels; selling drugs beyond the scope of business; failing to store drugs in accordance with regulations , Transportation, temperature and humidity monitoring, tampering with computer system, temperature and humidity monitoring system data, concealing real drug purchase and sales records, bills, vouchers, and data; investigation of illegal behaviors such as non-compliance of prescription drug sales and "certification" of licensed pharmacists.
Based on compliance inspections, they focus on purchasing drugs and recycling drugs through illegal channels; selling drugs beyond the scope of business; failing to store drugs in accordance with regulations , Transportation, temperature and humidity monitoring, tampering with computer system, temperature and humidity monitoring system data, concealing real drug purchase and sales records, bills, vouchers, and data; investigation of illegal behaviors such as non-compliance of prescription drug sales and "certification" of licensed pharmacists.
Anhui: In accordance with the unified deployment of the State Administration, focusing on drug wholesalers, drug retail companies, drug users, drug tripartite logistics companies and other entities, focusing on "calling tickets", computer system data inauthentic, illegal channel purchases, and illegal sales of prescription drugs , Licensed pharmacists, illegal recycling of drugs and packaging, illegal operation of drugs containing stimulants, etc.
to carry out special treatment.
to carry out special treatment.
Liaoning: Random inspections of pharmaceutical companies in Shenyang will be conducted at a rate of 50%, and full coverage inspections will be conducted in other regions.
Supervise and inspect the implementation of laws pharmnet.
com.
cn/" target="_blank">and regulations and related quality management practices by pharmaceutical business enterprises, and conduct supervision and inspection of key varieties such as vaccines, special drugs, drugs selected for centralized pharmnet.
com.
cn/news/yyzb/" target="_blank">procurement by the state , and Chinese medicine decoction pieces, purchase and sales channels, cold chain storage and transportation, "unified procurement and distribution", and personnel and other key aspects of performance of their duties, special drugs business enterprises , retail chain headquarters and other key enterprises, the implementation of key checks.
Supervise and inspect the implementation of laws pharmnet.
com.
cn/" target="_blank">and regulations and related quality management practices by pharmaceutical business enterprises, and conduct supervision and inspection of key varieties such as vaccines, special drugs, drugs selected for centralized pharmnet.
com.
cn/news/yyzb/" target="_blank">procurement by the state , and Chinese medicine decoction pieces, purchase and sales channels, cold chain storage and transportation, "unified procurement and distribution", and personnel and other key aspects of performance of their duties, special drugs business enterprises , retail chain headquarters and other key enterprises, the implementation of key checks.
Medical Network News on April 13
500,000 pharmacies, special inspections are coming
On April 12, the Ningxia Drug Administration issued the "Notice on Carrying out Special Inspections in Drug Circulation Links" (hereinafter referred to as the "Notice").
The "Notice" pointed out that in order to fully implement the "four most stringent" requirements for drug supervision and the newly revised "Drug Administration Law" to further standardize the order of the drug distribution market, according to the "National Drug Administration Department's special project on the development of drug distribution links" According to the requirements of the "Notice of Inspection Work" (Yao Jian Zong Yao Guan [2021] No.
35), it is decided to carry out special inspections of drug circulation links throughout the region from April to December 2021.
35), it is decided to carry out special inspections of drug circulation links throughout the region from April to December 2021.
It is worth noting that this "Notice" mentioned that it is in accordance with the requirements of the "Notice of the Comprehensive Department of the State Drug Administration on Carrying out Special Inspections in the Drug Circulation Link" (Yao Jian Zong Yao Guan [2021] No.
35), that is, This special inspection of the drug circulation link is nationwide.
Of course, it also includes retail pharmacies .
35), that is, This special inspection of the drug circulation link is nationwide.
Of course, it also includes retail pharmacies .
Judging from the target requirements and arrangements announced by the provinces, the inspections of retail pharmacies by the regulatory authorities this year are nationwide.
The Zhejiang Province notice clearly stated that it was formulated in accordance with the requirements of the 2021 National Drug Registration Management and Post-Marketing Regulatory Work Conference and the provincial bureau's key work arrangements for 2021.
The Zhejiang Province notice clearly stated that it was formulated in accordance with the requirements of the 2021 National Drug Registration Management and Post-Marketing Regulatory Work Conference and the provincial bureau's key work arrangements for 2021.
Shanxi Province also talked about resolutely implementing the "four most stringent" regulatory requirements, and arranging and deploying in accordance with the National Drug Registration Management and Post-Marketing Regulatory Work Conference and the Provincial Drug Supervision and Party Style and Clean Government Construction Work Conference to prevent risks, ensure safety, and strengthen Supervise, promote development, and effectively guarantee the safety of people's medication.
In addition, judging from the documents issued by Zhejiang, Shanxi, Anhui and other provinces, the focus is on the fundamental orientation of the "four strictest", which also means that this year’s inspections and penalties will be very strict, and retail pharmacies will be severely affected if they violate regulations.
Penalty.
Penalty.
7 types of pharmacies, key inspections
The "Notice" clarified that it is necessary to fully implement the main responsibilities of drug business and use units, strengthen supervision and inspection of key areas, key varieties, and key links, investigate and resolve hidden risks in drug circulation, and urge relevant units to operate and use drugs in accordance with laws and regulations.
According to the "Notice", 7 types of enterprises shall be inspected, specifically as follows:
1.
Pharmaceutical companies that have seriously violated the drug GSP since 2019;
Pharmaceutical companies that have seriously violated the drug GSP since 2019;
2.
Pharmaceutical companies that have repeatedly violated the drug GSP since 2019;
Pharmaceutical companies that have repeatedly violated the drug GSP since 2019;
3.
Drug dealers and users who have been complained and reported many times since 2019;
Drug dealers and users who have been complained and reported many times since 2019;
4.
Since 2019, the operating enterprises and users of unqualified drugs have been spot-checked;
Since 2019, the operating enterprises and users of unqualified drugs have been spot-checked;
5.
Pharmaceutical wholesale enterprises that entrust other enterprises to store and transport drugs (retail chain headquarters) and pharmaceutical wholesale enterprises that accept entrusted storage and transportation services;
Pharmaceutical wholesale enterprises that entrust other enterprises to store and transport drugs (retail chain headquarters) and pharmaceutical wholesale enterprises that accept entrusted storage and transportation services;
6.
Newly established pharmaceutical business enterprises since 2020;
Newly established pharmaceutical business enterprises since 2020;
7.
Other drug dealers and users that need to be inspected.
Other drug dealers and users that need to be inspected.
The key inspection varieties involve 5 categories, which are as follows:
1.
Refrigerated and frozen medicines such as vaccines, human albumin, and human immunoglobulin;
Refrigerated and frozen medicines such as vaccines, human albumin, and human immunoglobulin;
2.
Special drug compound preparations containing ephedrine, tramadol, diphenoxylate, etc.
;
Special drug compound preparations containing ephedrine, tramadol, diphenoxylate, etc.
;
3.
Drugs for the prevention and control of the new crown epidemic;
Drugs for the prevention and control of the new crown epidemic;
4.
Selected varieties in the centralized procurement of national drugs, etc.
;
Selected varieties in the centralized procurement of national drugs, etc.
;
5.
High-value antihypertensive and hypoglycemic drugs, cardiovascular and cerebrovascular drugs, and anti-tumor drugs are included in medical insurance drugs.
High-value antihypertensive and hypoglycemic drugs, cardiovascular and cerebrovascular drugs, and anti-tumor drugs are included in medical insurance drugs.
The inspection started in May, and the pharmacy focused on three major behaviors
The "Notice" talked about three stages: the mobilization and deployment stage (April 2021), the centralized inspection stage (May-October 2021), and the supervision and spot check stage (November-December 2021).
For pharmaceutical retail companies, the key inspection content is to carry out retail inspections focusing on retail pharmacies in urban-rural fringe areas, rural areas, and retail pharmacies around secondary medical institutions.
One is the inspection of drug purchase and sale channels.
Focus on checking the company's drug purchase and sales records, bills, and vouchers, whether there are illegal recycling or participation in illegal recycling of drugs, sales of recycled drugs, and illegal purchase and sale of preparations from medical institutions.
Focus on checking the company's drug purchase and sales records, bills, and vouchers, whether there are illegal recycling or participation in illegal recycling of drugs, sales of recycled drugs, and illegal purchase and sale of preparations from medical institutions.
The second is to check the availability of licensed pharmacists.
According to the "Notice of the State Drug Administration on Regulating the Provision and Use of Licensed Pharmacists in Drug Retail Enterprises" (National Drug Administration and Drug Administration ﹝2020﹞ No.
25) and the Autonomous Region Drug Administration’s "Notice on Issues Concerning the Management of the Distribution and Use of Licensed Pharmacists in Retail Pharmacies" ( Ningyao Jianfa [2020] No.
71) required to check whether retail pharmacies are equipped with licensed pharmacists (or pharmaceutical technicians) as required and whether they are practicing on the job.
According to the "Notice of the State Drug Administration on Regulating the Provision and Use of Licensed Pharmacists in Drug Retail Enterprises" (National Drug Administration and Drug Administration ﹝2020﹞ No.
25) and the Autonomous Region Drug Administration’s "Notice on Issues Concerning the Management of the Distribution and Use of Licensed Pharmacists in Retail Pharmacies" ( Ningyao Jianfa [2020] No.
71) required to check whether retail pharmacies are equipped with licensed pharmacists (or pharmaceutical technicians) as required and whether they are practicing on the job.
The third is the inspection of prescription drug sales.
Carry out a comprehensive inspection of the behavior of not selling prescription drugs in accordance with regulations, focusing on checking whether there is a failure to sell compound preparations containing special drugs, sales of vaccines, narcotic drugs, first-class psychotropic drugs, pharmaceutical precursor chemicals, pregnancy termination drugs, and traditional Chinese medicines.
Recipe granules and other drugs that are banned from retail by the state.
Carry out a comprehensive inspection of the behavior of not selling prescription drugs in accordance with regulations, focusing on checking whether there is a failure to sell compound preparations containing special drugs, sales of vaccines, narcotic drugs, first-class psychotropic drugs, pharmaceutical precursor chemicals, pregnancy termination drugs, and traditional Chinese medicines.
Recipe granules and other drugs that are banned from retail by the state.
In addition, each city should also monitor whether designated drug retail companies comply with the "Notice on Doing a Good Job in Drug Sales Monitoring During the Period of Normalization of the Prevention and Control of the New Coronary Pneumonia Epidemic" (Ning Yao Jianfa [2020] No.
51) and local joint prevention and control of the new crown pneumonia The mechanism requires inspection of the sales monitoring of four types of drugs, including fever, cough, antiviral, and antibacterial.
51) and local joint prevention and control of the new crown pneumonia The mechanism requires inspection of the sales monitoring of four types of drugs, including fever, cough, antiviral, and antibacterial.
Posting documents in many places, pharmacy inspections have started
According to a review, as of now, Jiangsu, Zhejiang, Shanxi, Anhui, Liaoning and other provinces have issued documents clarifying the inspection of retail pharmacies in 2021.
Jiangsu: Regarding the standardization of purchase and sales channels, business processes, and storage conditions, strengthen the supervision of business and use links.
Strengthen the supervision and inspection of pharmacists' on-the-job, prescription drug sales and other links, and increase the supervision of private medical institutions, plastic and cosmetic medical institutions, individual clinics, and maternal and child products specialty stores.
Strengthen the supervision and inspection of pharmacists' on-the-job, prescription drug sales and other links, and increase the supervision of private medical institutions, plastic and cosmetic medical institutions, individual clinics, and maternal and child products specialty stores.
Zhejiang: Unannounced inspections of retail companies are organized and arranged by local organizations; focus on inspections of pharmaceutical retail companies in rural areas of the urban-rural fringe, and pharmaceutical retail companies that carry out online ordering stores and online ordering stores.
The focus of the inspection is the following 11 behaviors:
The focus of the inspection is the following 11 behaviors:
1.
Whether the traceability system of key products (vaccine, special management drugs, blood products, national centralized procurement drugs) is complete;
Whether the traceability system of key products (vaccine, special management drugs, blood products, national centralized procurement drugs) is complete;
2.
Quality risk control involving counterfeit and inferior drugs (business scope, automatic control of drug expiration date, near-effective drug inventory management, etc.
), whether the inspection of drug packaging and properties is performed in strict accordance with the requirements of GSP;
Quality risk control involving counterfeit and inferior drugs (business scope, automatic control of drug expiration date, near-effective drug inventory management, etc.
), whether the inspection of drug packaging and properties is performed in strict accordance with the requirements of GSP;
3.
Whether to provide premises, qualification certificates, bills and other conditions for others to illegally trade drugs; purchase from individuals or units without "Drug Production License" and "Drug Distribution License", enterprises or institutions without "Drug Registration Certificate" Drugs; selling drugs to units or individuals without legal qualifications, knowing or ought to know that others are engaged in unlicensed business and still providing drugs for them;
Whether to provide premises, qualification certificates, bills and other conditions for others to illegally trade drugs; purchase from individuals or units without "Drug Production License" and "Drug Distribution License", enterprises or institutions without "Drug Registration Certificate" Drugs; selling drugs to units or individuals without legal qualifications, knowing or ought to know that others are engaged in unlicensed business and still providing drugs for them;
4.
Whether the person in charge of corporate quality and quality management personnel perform their duties; whether the licensed pharmacist is certified;
Whether the person in charge of corporate quality and quality management personnel perform their duties; whether the licensed pharmacist is certified;
5.
The company's cold chain drug management, whether the drug storage and transportation records are complete and true; whether the drug storage, transportation, and temperature and humidity monitoring are not performed in accordance with regulations; whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time;
The company's cold chain drug management, whether the drug storage and transportation records are complete and true; whether the drug storage, transportation, and temperature and humidity monitoring are not performed in accordance with regulations; whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time;
6.
Whether to falsify the source of drug purchases, fabricate the flow of drug sales, tamper with the computer system, temperature and humidity monitoring system data, conceal the real drug purchase and sale records, bills, vouchers, data, etc.
, the drug purchase and sale records are incomplete, untrue, and business operations cannot be performed Retrospective
Whether to falsify the source of drug purchases, fabricate the flow of drug sales, tamper with the computer system, temperature and humidity monitoring system data, conceal the real drug purchase and sale records, bills, vouchers, data, etc.
, the drug purchase and sale records are incomplete, untrue, and business operations cannot be performed Retrospective
7.
When purchasing and selling drugs, certificates (licenses), tickets (invoices, bills accompanying the goods), accounts (physical accounts, financial accounts), goods (physical drugs), and payments (payments) cannot correspond to each other; the drugs are not stored in the warehouse , Set up off-book accounts, drugs are not included in the enterprise quality management system, use bank personal accounts for business transactions, etc.
;
When purchasing and selling drugs, certificates (licenses), tickets (invoices, bills accompanying the goods), accounts (physical accounts, financial accounts), goods (physical drugs), and payments (payments) cannot correspond to each other; the drugs are not stored in the warehouse , Set up off-book accounts, drugs are not included in the enterprise quality management system, use bank personal accounts for business transactions, etc.
;
8.
Whether the drug is stored in a place other than the approved address; whether the registered address, business method, and business scope are sold without authorization;
Whether the drug is stored in a place other than the approved address; whether the registered address, business method, and business scope are sold without authorization;
9.
Failing to monitor the temperature and humidity of the storage and transportation of drugs in accordance with regulations;
Failing to monitor the temperature and humidity of the storage and transportation of drugs in accordance with regulations;
10.
Retail companies have problems selling prescription drugs and recalling drugs in violation of regulations;
Retail companies have problems selling prescription drugs and recalling drugs in violation of regulations;
11.
Other violations of laws and regulations.
Other violations of laws and regulations.
Shanxi: Pharmaceutical retail companies focus on prescription drugs, Chinese herbal medicines, and cold chain drugs.
Based on compliance inspections, they focus on purchasing drugs and recycling drugs through illegal channels; selling drugs beyond the scope of business; failing to store drugs in accordance with regulations , Transportation, temperature and humidity monitoring, tampering with computer system, temperature and humidity monitoring system data, concealing real drug purchase and sales records, bills, vouchers, and data; investigation of illegal behaviors such as non-compliance of prescription drug sales and "certification" of licensed pharmacists.
Based on compliance inspections, they focus on purchasing drugs and recycling drugs through illegal channels; selling drugs beyond the scope of business; failing to store drugs in accordance with regulations , Transportation, temperature and humidity monitoring, tampering with computer system, temperature and humidity monitoring system data, concealing real drug purchase and sales records, bills, vouchers, and data; investigation of illegal behaviors such as non-compliance of prescription drug sales and "certification" of licensed pharmacists.
Anhui: In accordance with the unified deployment of the State Administration, focusing on drug wholesalers, drug retail companies, drug users, drug tripartite logistics companies and other entities, focusing on "calling tickets", computer system data inauthentic, illegal channel purchases, and illegal sales of prescription drugs , Licensed pharmacists, illegal recycling of drugs and packaging, illegal operation of drugs containing stimulants, etc.
to carry out special treatment.
to carry out special treatment.
：50%，。pharmnet.
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com.
cn/news/yyzb/" target="_blank">、，、、“”、，、，。
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413
50，
50， 412，《》（《》）。
《》，“”《》，，《》（〔2021〕35），2021412，。
，《》《》（〔2021〕35），，。，。
，。，20212021。
，“”，，、，、，。
In addition, judging from the documents issued by Zhejiang, Shanxi, Anhui and other provinces, the focus is on the fundamental orientation of the "four strictest", which also means that this year’s inspections and penalties will be very strict, and retail pharmacies will be severely affected if they violate regulations.
Penalty.
Penalty.
7 types of pharmacies, key inspections
7 types of pharmacies, key inspections The "Notice" clarified that it is necessary to fully implement the main responsibilities of drug business and use units, strengthen supervision and inspection of key areas, key varieties, and key links, investigate and resolve hidden risks in drug circulation, and urge relevant units to operate and use drugs in accordance with laws and regulations.
According to the "Notice", 7 types of enterprises shall be inspected, specifically as follows:
1.
Pharmaceutical companies that have seriously violated the drug GSP since 2019;
Pharmaceutical companies that have seriously violated the drug GSP since 2019;
2.
Pharmaceutical companies that have repeatedly violated the drug GSP since 2019;
Pharmaceutical companies that have repeatedly violated the drug GSP since 2019;
3.
Drug dealers and users who have been complained and reported many times since 2019;
Drug dealers and users who have been complained and reported many times since 2019;
4.
Since 2019, the operating enterprises and users of unqualified drugs have been spot-checked;
Since 2019, the operating enterprises and users of unqualified drugs have been spot-checked;
5.
Pharmaceutical wholesale enterprises that entrust other enterprises to store and transport drugs (retail chain headquarters) and pharmaceutical wholesale enterprises that accept entrusted storage and transportation services;
Pharmaceutical wholesale enterprises that entrust other enterprises to store and transport drugs (retail chain headquarters) and pharmaceutical wholesale enterprises that accept entrusted storage and transportation services;
6.
Newly established pharmaceutical business enterprises since 2020;
Newly established pharmaceutical business enterprises since 2020;
7.
Other drug dealers and users that need to be inspected.
Other drug dealers and users that need to be inspected.
The key inspection varieties involve 5 categories, which are as follows:
1.
Refrigerated and frozen medicines such as vaccines, human albumin, and human immunoglobulin;
Refrigerated and frozen medicines such as vaccines, human albumin, and human immunoglobulin;
2.
Special drug compound preparations containing ephedrine, tramadol, diphenoxylate, etc.
;
Special drug compound preparations containing ephedrine, tramadol, diphenoxylate, etc.
;
3.
Drugs for the prevention and control of the new crown epidemic;
Drugs for the prevention and control of the new crown epidemic;
4.
Selected varieties in the centralized procurement of national drugs, etc.
;
Selected varieties in the centralized procurement of national drugs, etc.
;
5.
High-value antihypertensive and hypoglycemic drugs, cardiovascular and cerebrovascular drugs, and anti-tumor drugs are included in medical insurance drugs.
High-value antihypertensive and hypoglycemic drugs, cardiovascular and cerebrovascular drugs, and anti-tumor drugs are included in medical insurance drugs.
The inspection started in May, and the pharmacy focused on three major behaviors
The "Notice" talked about three stages: the mobilization and deployment stage (April 2021), the centralized inspection stage (May-October 2021), and the supervision and spot check stage (November-December 2021).
For pharmaceutical retail companies, the key inspection content is to carry out retail inspections focusing on retail pharmacies in urban-rural fringe areas, rural areas, and retail pharmacies around secondary medical institutions.
One is the inspection of drug purchase and sale channels.
Focus on checking the company's drug purchase and sales records, bills, and vouchers, whether there are illegal recycling or participation in illegal recycling of drugs, sales of recycled drugs, and illegal purchase and sale of preparations from medical institutions.
Focus on checking the company's drug purchase and sales records, bills, and vouchers, whether there are illegal recycling or participation in illegal recycling of drugs, sales of recycled drugs, and illegal purchase and sale of preparations from medical institutions.
The second is to check the availability of licensed pharmacists.
According to the "Notice of the State Drug Administration on Regulating the Provision and Use of Licensed Pharmacists in Drug Retail Enterprises" (National Drug Administration and Drug Administration ﹝2020﹞ No.
25) and the Autonomous Region Drug Administration’s "Notice on Issues Concerning the Management of the Distribution and Use of Licensed Pharmacists in Retail Pharmacies" ( Ningyao Jianfa [2020] No.
71) required to check whether retail pharmacies are equipped with licensed pharmacists (or pharmaceutical technicians) as required and whether they are practicing on the job.
According to the "Notice of the State Drug Administration on Regulating the Provision and Use of Licensed Pharmacists in Drug Retail Enterprises" (National Drug Administration and Drug Administration ﹝2020﹞ No.
25) and the Autonomous Region Drug Administration’s "Notice on Issues Concerning the Management of the Distribution and Use of Licensed Pharmacists in Retail Pharmacies" ( Ningyao Jianfa [2020] No.
71) required to check whether retail pharmacies are equipped with licensed pharmacists (or pharmaceutical technicians) as required and whether they are practicing on the job.
The third is the inspection of prescription drug sales.
Carry out a comprehensive inspection of the behavior of not selling prescription drugs in accordance with regulations, focusing on checking whether there is a failure to sell compound preparations containing special drugs, sales of vaccines, narcotic drugs, first-class psychotropic drugs, pharmaceutical precursor chemicals, pregnancy termination drugs, and traditional Chinese medicines.
Recipe granules and other drugs that are banned from retail by the state.
Carry out a comprehensive inspection of the behavior of not selling prescription drugs in accordance with regulations, focusing on checking whether there is a failure to sell compound preparations containing special drugs, sales of vaccines, narcotic drugs, first-class psychotropic drugs, pharmaceutical precursor chemicals, pregnancy termination drugs, and traditional Chinese medicines.
Recipe granules and other drugs that are banned from retail by the state.
In addition, each city should also monitor whether designated drug retail companies comply with the "Notice on Doing a Good Job in Drug Sales Monitoring During the Period of Normalization of the Prevention and Control of the New Coronary Pneumonia Epidemic" (Ning Yao Jianfa [2020] No.
51) and local joint prevention and control of the new crown pneumonia The mechanism requires inspection of the sales monitoring of four types of drugs, including fever, cough, antiviral, and antibacterial.
51) and local joint prevention and control of the new crown pneumonia The mechanism requires inspection of the sales monitoring of four types of drugs, including fever, cough, antiviral, and antibacterial.
Posting documents in many places, pharmacy inspections have started
Posting documents in many places, pharmacy inspections have started According to a review, as of now, Jiangsu, Zhejiang, Shanxi, Anhui, Liaoning and other provinces have issued documents clarifying the inspection of retail pharmacies in 2021.
Jiangsu: Regarding the standardization of purchase and sales channels, business processes, and storage conditions, strengthen the supervision of business and use links.
Strengthen the supervision and inspection of pharmacists' on-the-job, prescription drug sales and other links, and increase the supervision of private medical institutions, plastic and cosmetic medical institutions, individual clinics, and maternal and child products specialty stores.
Strengthen the supervision and inspection of pharmacists' on-the-job, prescription drug sales and other links, and increase the supervision of private medical institutions, plastic and cosmetic medical institutions, individual clinics, and maternal and child products specialty stores.
Zhejiang: Unannounced inspections of retail companies are organized and arranged by local organizations; focus on inspections of pharmaceutical retail companies in rural areas of the urban-rural fringe, and pharmaceutical retail companies that carry out online ordering stores and online ordering stores.
The focus of the inspection is the following 11 behaviors:
The focus of the inspection is the following 11 behaviors:
1.
Whether the traceability system of key products (vaccine, special management drugs, blood products, national centralized procurement drugs) is complete;
Whether the traceability system of key products (vaccine, special management drugs, blood products, national centralized procurement drugs) is complete;
2.
Quality risk control involving counterfeit and inferior drugs (business scope, automatic control of drug expiration date, near-effective drug inventory management, etc.
), whether the inspection of drug packaging and properties is performed in strict accordance with the requirements of GSP;
Quality risk control involving counterfeit and inferior drugs (business scope, automatic control of drug expiration date, near-effective drug inventory management, etc.
), whether the inspection of drug packaging and properties is performed in strict accordance with the requirements of GSP;
3.
Whether to provide premises, qualification certificates, bills and other conditions for others to illegally trade drugs; purchase from individuals or units without "Drug Production License" and "Drug Distribution License", enterprises or institutions without "Drug Registration Certificate" Drugs; selling drugs to units or individuals without legal qualifications, knowing or ought to know that others are engaged in unlicensed business and still providing drugs for them;
Whether to provide premises, qualification certificates, bills and other conditions for others to illegally trade drugs; purchase from individuals or units without "Drug Production License" and "Drug Distribution License", enterprises or institutions without "Drug Registration Certificate" Drugs; selling drugs to units or individuals without legal qualifications, knowing or ought to know that others are engaged in unlicensed business and still providing drugs for them;
4.
Whether the person in charge of corporate quality and quality management personnel perform their duties; whether the licensed pharmacist is certified;
Whether the person in charge of corporate quality and quality management personnel perform their duties; whether the licensed pharmacist is certified;
5.
The company's cold chain drug management, whether the drug storage and transportation records are complete and true; whether the drug storage, transportation, and temperature and humidity monitoring are not performed in accordance with regulations; whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time;
The company's cold chain drug management, whether the drug storage and transportation records are complete and true; whether the drug storage, transportation, and temperature and humidity monitoring are not performed in accordance with regulations; whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time;
6.
Whether to falsify the source of drug purchases, fabricate the flow of drug sales, tamper with the computer system, temperature and humidity monitoring system data, conceal the real drug purchase and sale records, bills, vouchers, data, etc.
, the drug purchase and sale records are incomplete, untrue, and business operations cannot be performed Retrospective
Whether to falsify the source of drug purchases, fabricate the flow of drug sales, tamper with the computer system, temperature and humidity monitoring system data, conceal the real drug purchase and sale records, bills, vouchers, data, etc.
, the drug purchase and sale records are incomplete, untrue, and business operations cannot be performed Retrospective
7.
When purchasing and selling drugs, certificates (licenses), tickets (invoices, bills accompanying the goods), accounts (physical accounts, financial accounts), goods (physical drugs), and payments (payments) cannot correspond to each other; the drugs are not stored in the warehouse , Set up off-book accounts, drugs are not included in the enterprise quality management system, use bank personal accounts for business transactions, etc.
;
When purchasing and selling drugs, certificates (licenses), tickets (invoices, bills accompanying the goods), accounts (physical accounts, financial accounts), goods (physical drugs), and payments (payments) cannot correspond to each other; the drugs are not stored in the warehouse , Set up off-book accounts, drugs are not included in the enterprise quality management system, use bank personal accounts for business transactions, etc.
;
8.
Whether the drug is stored in a place other than the approved address; whether the registered address, business method, and business scope are sold without authorization;
Whether the drug is stored in a place other than the approved address; whether the registered address, business method, and business scope are sold without authorization;
9.
Failing to monitor the temperature and humidity of the storage and transportation of drugs in accordance with regulations;
Failing to monitor the temperature and humidity of the storage and transportation of drugs in accordance with regulations;
10.
Retail companies have problems selling prescription drugs and recalling drugs in violation of regulations;
Retail companies have problems selling prescription drugs and recalling drugs in violation of regulations;
11.
Other violations of laws and regulations.
Other violations of laws and regulations.
Shanxi: Pharmaceutical retail companies focus on prescription drugs, Chinese herbal medicines, and cold chain drugs.
Based on compliance inspections, they focus on purchasing drugs and recycling drugs through illegal channels; selling drugs beyond the scope of business; failing to store drugs in accordance with regulations , Transportation, temperature and humidity monitoring, tampering with computer system, temperature and humidity monitoring system data, concealing real drug purchase and sales records, bills, vouchers, and data; investigation of illegal behaviors such as non-compliance of prescription drug sales and "certification" of licensed pharmacists.
Based on compliance inspections, they focus on purchasing drugs and recycling drugs through illegal channels; selling drugs beyond the scope of business; failing to store drugs in accordance with regulations , Transportation, temperature and humidity monitoring, tampering with computer system, temperature and humidity monitoring system data, concealing real drug purchase and sales records, bills, vouchers, and data; investigation of illegal behaviors such as non-compliance of prescription drug sales and "certification" of licensed pharmacists.
Anhui: In accordance with the unified deployment of the State Administration, focusing on drug wholesalers, drug retail companies, drug users, drug tripartite logistics companies and other entities, focusing on "calling tickets", computer system data inauthentic, illegal channel purchases, and illegal sales of prescription drugs , Licensed pharmacists, illegal recycling of drugs and packaging, illegal operation of drugs containing stimulants, etc.
to carry out special treatment.
to carry out special treatment.
Liaoning: Random inspections of pharmaceutical companies in Shenyang will be conducted at a rate of 50%, and full coverage inspections will be conducted in other regions.
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