Health

Two departments: Strengthen the management of drugs such as dexamethasone

2024-05-22   

The National Medical Products Administration and the National Health Commission recently issued a notice on strengthening the management of drugs such as dexamethasone (hereinafter referred to as the "Notice"). The Notice mentions that according to the Announcement on Adjusting the Catalogue of Psychotropic Drugs issued by the National Medical Products Administration, Ministry of Public Security, and National Health Commission (No. 54 of 2024), starting from July 1, 2024, dexamethasone (including salt, monotherapy, the same below), narfuraphine (including salt, isomer, and monotherapy, the same below), chlorkaserin (including salt, isomer, and monotherapy, the same below), and compound preparations containing diphenoate will be included in the second category of psychotropic drugs; Midazolam raw materials (including salts and isomers, the same below) and injections have been adjusted from Class II psychotropic drugs to Class I psychotropic drugs. The Notice requires that drug manufacturers producing raw materials and injections of dexamethasone, midazolam, and compound preparations containing diphenoate should apply for designated production qualifications for corresponding varieties from the provincial drug supervision and management department in accordance with the relevant provisions of the Regulations on the Administration of Anesthetic Drugs and Psychotropic Drugs and the Notice on Issuing the Measures for the Administration of the Production of Anesthetic Drugs and Psychotropic Drugs (Trial) (State Food and Drug Administration [2005] No. 528). Drug manufacturers producing dexamethasone and midazolam injections should apply for the 2024 production demand plan. Starting from July 1, 2024, enterprises that have not obtained the designated production qualification and production demand plan for corresponding varieties are not allowed to produce dexamethasone, narfurphine, chlorkasserine, compound preparations containing diphenoate, raw materials of midazolam, and injections. The above-mentioned varieties shall not be commissioned for production. Holders and manufacturers of marketing permits for dexamethasone, narfurphine, and compound preparations containing diphenoxylate shall strictly follow the provisions of the Drug Registration Management Measures (Order No. 27 of the State Administration for Market Regulation) to handle the corresponding procedures for changing drug labels and instructions. Starting from October 1, 2024, all manufactured and imported compound formulations of dexamethasone, narfurphine, and diphenoate must have the specified identification on their labels and instructions. The above-mentioned varieties previously produced and imported can continue to be circulated and used within their validity period. The Notice also requires that from the date of publication of this notice, drug trading enterprises that do not have the qualifications for the operation of Class II psychotropic drugs shall not purchase compound preparations containing dexamethasone, narfurphine, and diphenoxylate. The original inventory products shall be registered and reported to the department responsible for drug supervision and management in the locality, and shall be sold out according to regulations; Drug trading enterprises that do not have the qualification for operating Class I psychotropic drugs are not allowed to purchase midazolam injections anymore, and their existing inventory products will be returned through the original channels. Starting from July 1, 2024, the development, purchase, mailing, transportation, and import and export of dexamethasone, nifurane, chlorcarbazepine, compound preparations containing difenoxylate, midazolam raw materials and injections shall comply with the relevant requirements for the management of psychotropic drugs under the Drug Administration Law and the Regulations on the Administration of Anesthetic and Psychotropic Drugs. Starting from July 1, 2024, medical institutions shall purchase, store, and use compound preparations of dexamethasone, narfurphine, and diphenoate in accordance with Class II of the Regulations on the Administration of Anesthetic Drugs and Psychotropic Substances

Edit:GuoGuo Responsible editor:FangZhiYou

Source:People.cn

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