84888 retail pharmacies that have been investigated and dealt with at times need to be wary of the 5 major...

Last year, 84,888 sub-pharmacies were investigated and dealt with.

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Among them, 47,500 wholesale companies were inspected, 5,855 companies were found to have violated the relevant management regulations on drug business, and 6,451 rectifications were completed.

A review found that among the 84888 sub-pharmaceutical retail companies, 6661 sub-pharmacies were investigated for serious violations of the GSP, 281 were due to counterfeit drugs, 1949 were due to inferior drugs, and 262 were due to involvement.

5 types of violations, severely investigated and punished

Regarding serious violations of GSP, retail counterfeit drugs, retail inferior drugs, unlicensed operation, and purchasing drugs through illegal channels, the author emphasizes that in accordance with the new version of the "Drug Administration Law", once these violations are involved, they will be severely affected.

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Retail pharmacies, new inspections are coming

In accordance with the “Notice on Carrying out Special Inspections on Drug Circulation Links” (Yao Jian Zong Yao Guan [2021] No.

Take Beijing as an example.

According to documents issued by local drug regulatory authorities, Cyberlan-pharmacy managers have sorted out 10 key points for rectification.

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Check the sales of prescription drugs.
Focus on checking whether there are any behaviors that have not been sold in accordance with regulations that contain special drug compound preparations, sales of vaccines, narcotic drugs, first-class psychotropic drugs, pharmaceutical precursor chemicals, pregnancy termination drugs, traditional Chinese medicine formula particles, and other drugs that are prohibited by the state from retail, etc.
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Inspection of illegal activities of drug online sales.
The focus will be on the issue of unqualified drug online sales, drug online sellers selling drugs through the Internet in violation of laws and regulations, and the performance of third-party platforms for online transaction services.

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Whether the traceability system of key products (vaccine, special management drugs, blood products, national centralized procurement drugs) is complete.

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Quality risk control involving counterfeit and inferior drugs (business scope, automatic control of drug expiry 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.

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The enterprise'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.

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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 to sell drugs beyond the business scope.

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Whether the drug storage, transportation, temperature and humidity monitoring, computer system, temperature and humidity monitoring system data are tampered with, and the real drug purchase and sales records, bills, vouchers, and data are concealed.

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Focus on the investigation of new coronavirus detection reagents, ventilators, medical protective clothing, medical masks, and infrared thermometers, and other epidemic prevention and control medical equipment, especially enterprises that have been approved for production and cross-border conversion, as well as product quality that is unqualified and defective And other enterprises.