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The three departments further strengthen the management of drugs such as Pregabalin
The National Medical Products Administration, Ministry of Public Security, and the Office of the National Narcotics Control Commission recently issued a joint notice, deciding to further strengthen the management of pregabalin oral monotherapy preparations and Yumei preparations (containing only dextromethorphan and guaifenesin/guaicolglycerol ether, hereinafter the same). The goal is to prevent medicines from entering illegal channels and being abused. The notice clarifies that provincial drug supervision administrations will strictly control the approval of raw material drug plans needed for Yumei preparations. The annual usage of enterprises should generally not exceed that of the previous year. For enterprises found with a large number of related preparations seized from illegal channels, their raw material drug plans will be appropriately reduced. Holders of drug marketing licenses and wholesale enterprises must verify the qualifications of buyers and procurement personnel, track drug arrivals, prohibit cash transactions, regularly monitor sales, and promptly stop sales and report in case of abnormal buyers; online retail of related preparations is prohibited. Retail pharmacies must set up dedicated counters and personnel, register in dedicated books, sell prescription drugs only with licensed physicians’ prescriptions and keep the prescriptions, and sell non-prescription drugs in no more than five minimum packages per sale. Sales to minors are strictly forbidden. If abnormal purchasing behavior is detected, sales must be refused and reported. The notice requires that relevant drug marketing license holders establish an information traceability system to ensure production and sales are traceable and verifiable, and to promptly handle abnormal sales situations. Drug trading enterprises must verify traceability information during procurement and acceptance, and immediately stop purchasing and selling and report if abnormalities are found. Additionally, provincial drug supervision administrations will include two categories of drugs in the key monitoring varieties for drug abuse, improve early warning mechanisms, and promptly address abuse risks. All levels of drug supervision administrations will strengthen supervision at all stages and severely investigate violations; public security organs will lawfully investigate illegal public security management behaviors, initiate criminal investigations for suspected crimes, and maintain a high-pressure crackdown stance. (Xinhua News Agency)