4HtSOKIvhGz health.huanqiu.com article Two departments: strengthen the management of dextromethorphan and other drugs to prevent them from flowing into illegal channels /e3pmt7dq2/e3pn4alr1 <article><section data type="rtext"><p>[Global Network Report] According to the website of the State Food and Drug Administration, the State Food and Drug Administration and the National Health Commission recently issued a notice on strengthening the administration of dextromethorphan and other drugs</ p> <p>According to the Announcement of the State Food and Drug Administration, the Ministry of Public Security and the National Health Commission on the Adjustment of the Catalogue of Psychotropic Drugs (No. 54 in 2024), from July 1, 2024, dextromethorphan (including salt, single preparations, the same below), nafurarphine (including salt, isomers and single preparations, the same below), chlorkaserin (including salt, isomers and single preparations, the same below) Compound preparations containing diphenoxylate are listed in the second category of psychotropic drugs; Midazolam drug substance (including salt, isomer, the same below) and injection were adjusted from the second category of psychotropic drugs to the first category of psychotropic drugs. In accordance with the Drug Administration Law, the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs and other laws and regulations, and in combination with the adjustment of the list of psychotropic drugs and the marketing of drugs, the relevant matters are notified as follows:</p><p>I. The production of dextromethorphan, midazolam APIs and injections Drug manufacturing enterprises containing compound preparations of diphenoxylate shall apply to the local provincial drug supervision and administration department for the qualification of designated production of corresponding varieties in accordance with the relevant provisions of the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs, the Notice on Printing and Distributing the Measures for the Administration of the Production of Narcotic Drugs and Psychotropic Drugs (Trial) (GSYJA [2005] No. 528). Drug manufacturers producing dextromethorphan and midazolam injection shall declare the production demand plan for 2024</ p> <adv-loader __attr__inner="7004636" __attr__style="width: auto; position: relative;float: left;border: 1px solid #ebebeb; padding: 20px;overflow: hidden;margin: 10px 30px 40px 0; "></adv-loader> <p>2、 From July 1, 2024, enterprises that have not obtained the qualification for designated production of corresponding varieties and the production demand plan shall not produce dextromethorphan, nafurarphine, clocasserin, compound preparations containing diphenoxylate, midazolam APIs and injections. The above varieties shall not be commissioned for production</ p> <p>III. The holders and manufacturers of the marketing license of dextromethorphan, nafurarphine, and compound preparations containing diphenoxylate shall go through the formalities for the change of the corresponding drug labels and instructions in strict accordance with the Measures for the Administration of Drug Registration (Order No. 27 of the State Administration of Market Supervision and Administration). From October 1, 2024, all dextromethorphan, nafurarphine, and diphenoxylate containing compound preparations manufactured, delivered, and imported must be printed with the specified marks on their labels and instructions. The above varieties produced, delivered and imported before can continue to circulate and use within the validity period</ p> <p>IV. Since the issuance of this notice, drug distributors without the qualification for the distribution of psychotropic drugs in the second category shall not purchase dextromethorphan, nafurarphine, and compound preparations containing diphenoxylate. The original inventory of products shall be registered and recorded and reported to the local department responsible for drug supervision and management, and then sold out as required; Drug distributors who do not have the first class psychotropic drug business qualification shall not purchase midazolam injections, and the original inventory products shall be returned to the original channels</ p> <p>V. From July 1, 2024, the development, purchase, mailing, transportation, import and export of dextromethorphan, nafurarphine, clocasserin, compound preparations containing diphenoxylate, midazolam bulk drugs and injections should comply with the requirements of the Drug Administration Law, the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances for the administration of psychotropic drugs</ p> <p>VI. From July 1, 2024, medical institutions shall purchase, store and use dextromethorphan, nafurarphine and compound preparations containing diphenoxylate in accordance with the relevant provisions of the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances on the management of Category II psychotropic substances; Midazolam injection shall be implemented in accordance with the relevant provisions of the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances on the management of Class I psychotropic substances</ p> <p>VII. The drug marketing license holders and drug manufacturing and trading enterprises of dextromethorphan, nafurarphine, and compound preparations containing diphenoxylate shall establish and implement a traceability system for the above drugs in accordance with the Drug Administration Law and other laws and regulations, and provide traceability information in accordance with the provisions. Medical institutions shall provide drug traceability information in accordance with the requirements of laws and regulations such as the Drug Administration Law</ p> <p>Drug regulatory authorities at all levels should strengthen the supervision and management of the development, production and marketing of dextromethorphan and other psychotropic drugs in drug enterprises; The health departments at all levels shall strengthen the supervision and management of the use of psychotropic drugs in medical institutions, urge the relevant units to strictly implement the above provisions, ensure medical needs and prevent them from flowing into illegal channels</ p></section></article> one trillion and seven hundred and sixteen billion three hundred and forty-five million one hundred and thirty-four thousand eight hundred and seventy-four Copyrighted works of Globegroup are strictly prohibited from being reproduced or mirrored without written authorization. Violators will be investigated for legal responsibility. Editor in charge: Li Qingyun Global Network one trillion and seven hundred and sixteen billion three hundred and forty-five million one hundred and thirty-four thousand eight hundred and seventy-four one one []