The pharmacy's strictest inspection and punishment is coming

In 2021, retail pharmacies will usher in the strictest inspections and strictest penalties.

Multi-departmental cooperation, will check pharmacies

On March 12, the official WeChat account of the Jiangsu Provincial Food and Drug Administration announced the "Key Points of Provincial Drug Supervision in 2021" (hereinafter referred to as "Key Points"), and clearly defined the need to regulate the business and use of drugs to ensure the safety of drug use by the masses.

The "Key Points" pointed out that in view of the standardization of purchase and sales channels, business processes, and storage conditions, the supervision of business and use links should be strengthened.

At the same time, "Key Points" talked about the need to implement the regulatory requirements for drug business and use under the provincial bureau's new system, strengthen the business guidance for grassroots work, and establish and improve the contact point system for drug and device business and use supervision.

In addition, the "Key Points" also emphasized to strengthen external communication and coordination with health, public security, medical insurance and other departments, promote internal collaboration and linkage between inspection sub-bureaus and city and county supervision bureaus, and establish a joint inspection and information notification mechanism.

Pharmacy, the strictest inspection and punishment are coming

Cyber ​​Blue-a pharmacy manager combed and found that up to now, 5 provinces have issued documents clarifying the inspection of retail pharmacies in 2021.

On the 5th of this month, Zhejiang Food and Drug Administration issued the "Notice on Organizing and Carrying out Unannounced Inspections of Drugs GSP in 2021.

Shanxi Province’s "Notice on the Provincial Drug Circulation Supervision and Inspection Work Plan in 2021" also talked about resolutely implementing the "four most stringent" regulatory requirements, in accordance with the National Drug Registration Management and Post-Marketing Regulatory Work Conference and the provincial drug regulatory and party style The clean government construction work conference is arranged and deployed to prevent risks, ensure safety, strengthen supervision and promote development, and effectively ensure the safety of people's drug use.

In addition, it is worth mentioning that, 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.

Many provinces have issued documents, and the inspection will start soon

The author sorted out the key points and requirements for the renovation of retail pharmacies based on the documents of various provinces.

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.

1.

2.

3.

4.

5.

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

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 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;

9.
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;

11.
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.

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.

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.
Carry out supervision and inspection on the implementation of laws and regulations and related quality management practices by pharmaceutical business enterprises, and carry out supervision and inspection of vaccines, special drugs, national centralized procurement drugs, Chinese herbal medicines and other key varieties, purchase and sales channels, cold chain storage and transportation, "unified procurement and distribution", and personnel In key links such as job performance, special drug dealers, retail chain headquarters and other key enterprises, implement key inspections.