The focus of retail pharmacy inspections is here

In 2021, the focus of pharmacy inspections is coming

On February 23, the Anhui Provincial Food and Drug Administration issued a notice on the "2021 Provincial Drug and Medical Device Circulation Risk Prevention and Control Supervision and Inspection Plan" (hereinafter referred to as the "Plan").

According to the "Plan", in 2021, the supervision of the circulation of pharmaceutical equipment in the province will be guided by the "four most stringent", with risk control as the starting point, and daily inspections, special inspections, unannounced inspections, and "double random" inspections.

The "Plan" talked about seven key tasks, namely, carrying out special drug supervision and inspection, carrying out special inspections of vaccines (new crown vaccine), carrying out special inspections of epidemic prevention and control medical equipment operation, carrying out targeted inspections of medical equipment users, and carrying out online sales of medicines and medical treatment.

Regarding the key points of special rectification in the pharmaceutical business, the "Plan" clarifies that, in accordance with the unified deployment of the State Administration, it will focus on pharmaceutical wholesalers, pharmaceutical retail enterprises, pharmaceutical users, pharmaceutical tripartite logistics enterprises and other subjects, focusing on "linked tickets" and computer system data Special treatments were carried out for untrue, illegal purchases of prescription drugs, illegal sales of prescription drugs, “licensing” of licensed pharmacists, illegal recycling of drugs and packaging, and illegal operation of drugs containing stimulants.

Retail pharmacies, submit a self-inspection report before the end of November

In accordance with the requirements of the "Plan", the supervision of drug business links will be supervised by each city bureau over the headquarters of drug retail chain enterprises, drug and medical device network sales companies, vaccine distribution companies, and disease prevention and control institutions (the Provincial Center for Disease Control and Prevention is governed by the Hefei Municipal Bureau).

At the same time, it integrates the supervision resources of county bureaus and organizes flights to pharmaceutical retail enterprises (focus on urban-rural fringe and rural areas pharmaceutical retail enterprises, single pharmacies), medical device operating enterprises, and medical institutions (focus on individual clinics and vaccination units) Inspection, the inspection ratio is determined by yourself.

Each county bureau is responsible for formulating the annual supervision and inspection plan at the same level; organizes the supervision and inspection of the quality and safety of pharmaceutical equipment in the area of ​​the drug retail enterprises, medical device business enterprises, medical institutions, drug and medical device network sales enterprises, disease prevention and control institutions, and inoculation units; organization; Carry out training for relevant pharmaceutical equipment circulation supervisors and enterprise (unit) quality management personnel.

In addition, the "Plan" also pointed out that the regulatory authorities at all levels should supervise and urge drug distributors to conduct self-inspection and submit a self-inspection report to the regulatory authorities in the jurisdiction before the end of November.

Attachment: List of key inspection contents for risk prevention and control in the circulation of pharmaceuticals and medical devices in 2021