I took a picture of the Chinese stuff and had Google translate it. Here is what this thing says. Long read but it seems that certain psychopic drugs are on the hit list. Not sure about other stuff because it's not mentioned. And if you have proper licensing you can continue to do manufacturing of drugs. But without the proper permits they will go after you.
Notice of the Beijing Municipal Drug Administration on Further Strengthening the Management of Dextromethorphan and Other Drugs - Beijing Drug Administration [2024] No. 117
2024.05.28
Beijing Municipal Drug Administration
To the Market Supervision Bureaus of all districts, the Yanshan Market Supervision Branch of Fangshan District, the Airport Branch of the Municipal Market Supervision Bureau, the Commerce and Finance Bureau of the Economic Development Zone, all branches of the Municipal Drug Administration, and all pharmaceutical production and operation enterprises:
On April 30, 2024, the National Medical Products Administration, the Ministry of Public Security, and the National Health Commission issued the "Announcement of the National Medical Products Administration, the Ministry of Public Security, and the National Health Commission on Adjusting the Catalog of Psychotropic Drugs" (No. 54 of 2024). In order to strengthen the management of dextromethorphan and other drugs, the National Medical Products Administration and the National Health Commission issued the "Notice on Strengthening the Management of Dextromethorphan and Other Drugs" (National Medical Products Administration Drug Administration [2024] No. 16, hereinafter referred to as the National Notice). Now, in accordance with the duties, the city's implementation requirements are notified as follows:
1. Pharmaceutical manufacturers producing dextromethorphan, midazolam APIs and injections, and diphenoxylate-containing compound preparations shall apply to the Municipal Food and Drug Administration for designated production qualifications for the corresponding varieties in accordance with the relevant provisions of the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs and the Notice on Issuing the Regulations on the Administration of the Production of Narcotic Drugs and Psychotropic Drugs (Trial) (State Food and Drug Administration [2005] No. 528); pharmaceutical manufacturers producing dextromethorphan and midazolam injections shall declare the production demand plan for 2024. The production demand plan for 2024 can be reported and filed at any time before December 31, 2024, but only once.
2. Pharmaceutical manufacturers that use dextromethorphan to produce compound preparations should submit and file the annual dextromethorphan demand plan on schedule in accordance with the relevant provisions of the "Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs" and the "Notice on Issuing the "Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs Production (Trial)" (State Food and Drug Administration [2005] No. 528). In order to meet the drug production needs in 2024, if the company has a dextromethorphan procurement plan from July 1 to December 31, 2024, it should apply to the Municipal Drug Administration for filing of the demand plan before June 30, 2024. If there is no procurement plan during this period, the company should report the dextromethorphan inventory quantity and safety management status and other information to the affiliated drug supervision bureau before June 15, 2024, and there is no need to file a demand plan.
3. From July 1, 2024, enterprises that have not obtained the designated production qualification and production plan for the corresponding varieties shall not produce dextromethorphan, nalfuraphine, lorcaserin, compound preparations containing diphenoxylate, midazolam raw materials and injections. The above varieties shall not be commissioned for production. Enterprises that have not obtained the designated production qualification for the corresponding varieties should formulate special systems and regulations for their inventory of raw materials and preparations to standardize the management of storage links, and those that need to be destroyed should apply for supervised destruction.
4. The marketing authorization holders and manufacturers of dextromethorphan, nalfuraphine, 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 change procedures for the corresponding drug labels and instructions. From October 1, 2024, all dextromethorphan, nalfuraphine, and compound preparations containing diphenoxylate produced and imported must have the prescribed logo printed on their labels and instructions. The above varieties previously produced and imported can continue to be circulated and used within the validity period.
5. From the date of the issuance of the national notice, pharmaceutical companies that do not have the qualifications to operate the second-class psychotropic drugs shall no longer purchase dextromethorphan, nalfuraphine, and compound preparations containing diphenoxylate. Pharmaceutical companies that do not have the qualifications to operate the first-class psychotropic drugs shall no longer purchase midazolam injections, and the original inventory products shall be returned through the original channels.
6. Pharmaceutical production and operation enterprises that have not obtained the corresponding qualifications for Class II psychotropic drugs, if they have a need to sell dextromethorphan, nalfuraphine, and compound preparations containing diphenoxylate due to inventory reasons after July 1, 2024, should formulate special systems and procedures to standardize the management of storage, sales, and transportation links, and apply for supervised destruction if they need to destroy them. Enterprises with sales needs should report the inventory varieties to their respective drug supervision bureaus or district-level market supervision departments before June 15, 2024 for registration; they should also submit a self-inspection report on the management of psychotropic drug sales, storage, and safety management in accordance with the provisions of laws and regulations such as the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs and the Measures for the Administration of Narcotic Drugs and Psychotropic Drugs (Trial) .
7. Before July 1, 2024, it is the transitional stage for the listing of varieties. Drug marketing authorization holders, drug manufacturers and drug dealers should earnestly implement their main responsibilities, formulate special documents, and strengthen the management of the procurement, storage, transportation, sales, returns, destruction and other links of the varieties listed in the announcement. Enterprises should also strictly follow the requirements of the "Notice on Further Strengthening the Management of Compound Diphenoxylate Tablets and Other Drugs by the General Department of the State Drug Administration, the General Office of the Ministry of Public Security, and the General Office of the State Post Bureau" (No. 13 of the General Drug Administration of the State Drug Administration [2023], see attachment), strictly review the qualifications of the purchaser of dextromethorphan oral monopreparation and compound diphenoxylate tablets, and shall not sell drugs to enterprises, institutions or individuals that do not have the corresponding qualifications. Strictly review and inspect the entry and exit of drugs, and strictly prevent the occurrence of fraudulent purchases and arbitrage purchases of drugs by forging qualifications. The storage and transportation process of drugs should be included in the scope of business management to ensure that the whole process meets the relevant requirements of the drug business quality management specifications. Drug retail enterprises strictly implement the regulations on the sale of prescription drugs with prescriptions. The relevant varieties shall not be sold online. During the transition period, enterprises are encouraged to carry out production and business activities in accordance with the relevant requirements of the Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs, the Measures for the Administration of the Production of Narcotic Drugs and Psychotropic Drugs (Trial Implementation) and the Measures for the Administration of the Business of Narcotic Drugs and Psychotropic Drugs (Trial Implementation).
8. From July 1, 2024, the development, purchase, mailing, transportation, import and export of dextromethorphan, nalfuraphine, lorcaserin, diphenoxylate-containing compound preparations, midazolam raw materials and injections shall comply with the relevant psychotropic drug management requirements of the "Drug Administration Law" and the "Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs".
9. The drug marketing authorization holders and drug production and operation enterprises of dextromethorphan, nalfuraphine, and compound preparations containing diphenoxylate shall establish and implement a traceability system for the above-mentioned drugs in accordance with the requirements of the Drug Administration Law and other laws and regulations, and provide traceability information in accordance with the regulations.
10. The market supervision bureaus of each district, the Yanshan Market Supervision Branch of Fangshan District, the Airport Branch of the Municipal Market Supervision Bureau, the Commerce and Finance Bureau of the Economic Development Zone, and the branches of the Municipal Drug Administration should strengthen the supervision and management of the research, production and operation of psychotropic drugs such as dextromethorphan by pharmaceutical companies in accordance with their duties, and strictly follow the requirements of the "Notice of the Beijing Municipal Drug Administration on Carrying out Special Inspections on the Production and Operation of Class II Psychotropic Drugs" (Beijing Drug Supervision and Administration [2024] No. 106), list the varieties involved in the announcement as key varieties for special inspections on the production and operation of Class II psychotropic drugs, organize relevant pharmaceutical production and operation companies to conduct self-inspection and self-correction, report the self-inspection of enterprises, and strengthen supervision of registered enterprises. In conjunction with special inspections and other work, we must strengthen work guidance for relevant enterprises and do a good job in policy publicity, with a focus on enterprises that are involved in the production and operation of psychotropic drugs for the first time. Those who are found to have violated the "Drug Administration Law of the People's Republic of China" and the "Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs" and other laws and regulations, resulting in the flow of drugs into illegal channels, causing drug abuse or causing harm, shall be dealt with strictly and severely in accordance with the law and duties; if a crime is constituted, it shall be transferred to the public security organs in a timely manner.
Please be notified.
Attachment: "Notice of the General Department of the National Drug Administration, the General Office of the Ministry of Public Security, and the General Office of the State Post Bureau on Further Strengthening the Management of Compound Diphenoxylate Tablets and Other Drugs" (Drug Supervision General Drug Administration [2023] No. 13)
Beijing Municipal Drug Administration
May 27, 2024
appendix
