Three provinces issued documents to start the inspection of retail pharmacies in 2021

Medical Network News on February 26 As of now, three provinces have issued documents to start the inspection of retail pharmacies in 2021
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The Drug Administration issued a document focusing on investigating such pharmacies.

On February 24, the Shanxi Provincial Drug Administration issued the "Notice on Carrying out Supervision and Inspection of Special Drugs" (hereinafter referred to as the "Notice")
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The "Notice" clearly stated that it is necessary to comprehensively promote the retrospective management of drug information, focus on eliminating hidden dangers in the safety management of special drugs in the production, operation and use of special drugs, severely crack down on violations of laws and regulations, and strictly prevent illegal channels from entering illegal channels to ensure that special drugs can be managed and used.
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As for the scope of inspection, the "Notice" clarifies four types of enterprises, involving retail chain headquarters and retail pharmacies
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First, psychotropic drugs (including raw materials), medical toxic drug manufacturers, and those using narcotic drugs and psychoactive drugs (including non-drug manufacturers); second, narcotic drugs, psychotropic drugs, and pharmaceutical precursor chemicals Designated operating enterprises of toxic drugs for medical use (including wholesale companies, retail chain headquarters and retail pharmacies); Third, medical institutions that use narcotic drugs, psychotropic drugs, pharmaceutical precursor chemicals, toxic drugs for medical use, and radiopharmaceuticals (Including health centers, private hospitals , individual clinics, and outpatient detoxification maintenance treatment clinics); Fourth, use units that apply for the purchase of reference substances for narcotic drugs and psychotropic drugs in 2020
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Among them, the key points of inspection are as follows: 1.
Whether the safety management system covers procurement, storage, sales, transportation and other links; 2.
Whether the two-person management is strictly implemented, whether the inspection and acceptance is to the smallest packaging, and the special account is registered Whether it is true and accurate; 3.
Whether the special warehouse (cabinet) facilities, video surveillance and alarm equipment are operating normally; 4.
Whether the receiving place is the address specified in the permit, and whether the delivery receipt has the signature (seal) of an authorized person; whether Establish an information-based traceability system to scan codes for special drugs purchased and sold for verification and write-off; 5.
Whether anesthetic drugs, psychotropic drugs, and pharmaceutical precursor chemicals sold to medical institutions are sold through the seal card platform and whether they are sold separately Issue accompanying documents and value-added tax invoices, and achieve one ticket for one item
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The three provinces announced that they will strictly investigate these behaviors in pharmacies this year .

In addition, it is not only Shanxi Province that has announced the retail pharmacy inspection plan for 2021.
Prior to this, Anhui and Liaoning provinces also clarified their regulatory plans for 2021
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On February 23, the Anhui Provincial Food and Drug Administration issued the "2021 Provincial Drug and Medical Device Circulation Risk Prevention and Control Supervision and Inspection Plan
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" It explicitly, according to the National Bureau of unified arrangements around the pharmaceutical wholesale business subject, drug retailers, drug use units, drug party logistics enterprises, focusing on "anchored go vote", the computer system data is untrue, illegal channels to purchase, illegal Sale of prescription drugs, "licensing" of licensed pharmacists, illegal recycling of drugs and packaging, illegal operation of drugs containing stimulants, etc.
to carry out special treatment
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(The list of key inspection contents for risk prevention and control in the circulation of pharmaceuticals and medical devices in 2021) On February 9, the "Liaoning Provincial Drug Administration 2021 Supervision and Inspection Plan" issued by the Liaoning Provincial Drug Administration also mentioned that drugs should be treated according to risk levels.
Wholesale enterprises, retail chain headquarters, and online sales third-party platforms implement risk classification supervision, and inspect at least once a quarter for wholesale enterprises dealing in narcotic drugs, first-class psychoactive drugs, and pharmaceutical precursor chemicals; The second-class psychotropic drugs and the national centralized procurement of selected drug wholesale enterprises shall be inspected at least once a year
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It should be noted that the plan of Liaoning Province also emphasizes that 50% of the drug dealers in Shenyang will be randomly inspected, and other areas will be inspected for full coverage
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This also shows that with the exception of Shenyang, pharmacies in other places in Liaoning Province must be inspected
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As for the inspection schedule and content of drug distribution companies, it is required to complete the supervision and inspection before the end of November
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Supervise and inspect the implementation of laws 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 procurement by the state, and Chinese medicine decoction pieces, 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
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