The business scope of medical herbal therapy preparations includes

The first is to obtain the approval number of the National Drug Approval with the prefix Z (traditional Chinese medicine preparations) or the National Drug Approval with the prefix B (health care drugs), and clearly label the wholesale and retail of herbal preparations that can be used for auxiliary treatment/intervention in medical scenarios.； Second, in-hospital herbal preparations that have obtained preparation registration/filing approval from medical institutions must be dispensed and sold within the scope of the approved medical institution. ； The third is the self-made herbal preparations registered by the local health department in grassroots TCM clinics and prescribed to patients in the clinic setting.

When I was helping a friend to get the qualifications to run a traditional Chinese medicine clinic, the staff at the window repeatedly emphasized this boundary to me. There were really too many people who stepped on the trap - many people thought that as long as the raw materials were Chinese herbal medicines and they were effective when used by themselves, they could fall into the "medical" category. In fact, it is far from the truth.

For example, Brother Zhang, who runs a community Chinese medicine clinic that I know, prepared a Lithospermum ointment to relieve eczema in children two years ago. The raw materials are all medicinal and edible herbs, and he brought them to the parents of children who came to the clinic for massage. He was originally well-intentioned, but he was reported for selling "three-no medicines" and was fined nearly RMB 100,000. The company was also suspended for half a month for rectification. Later, he went to the Health Commission three times to complete the registration of self-made preparations in grassroots clinics. Now this ointment can only be prescribed to patients who come to the clinic to register for treatment, and cannot be sold to individual customers. Only then does it fall within the legal scope of business.

There are actually industry disputes here, and the attitude of the regulatory authorities has always been clear: as long as the product claims to have the functions of treatment, diagnosis, and disease intervention, it must be classified into the scope of drug/medical institution preparation management. Without approval, it cannot be included in the business scope of medical herbal preparations, regardless of how many years the prescription has been used and whether it has any effect. However, many veteran traditional Chinese medicine practitioners at the grassroots level do not actually believe this statement: many traditional Chinese medicine prescriptions are handed down from their ancestors, and the complete in-hospital preparation approval process costs millions, and small clinics cannot afford it. As long as the prescription has been used for decades without adverse reactions and the doctor who prescribes it has professional qualifications, it should be allowed to be used on a small scale and be considered a legal operation. Now many pilot areas in Jiangsu, Zhejiang and Guangdong have relaxed their rules. As long as the clinic is registered, the doctor has complete qualifications, and the homemade herbal preparations are not circulated to the outside world, they can be considered within the scope of legal business, and there is no need to go through complicated registration procedures.

One point that many people are still confused about is whether herbal disinfectant ointments from Xiaozihao, herbal skin care products from Zhuangzihao, and herbal health care ointments from Shizihao can be considered medical herbal preparations? The answer is absolutely not. No matter how many Chinese herbal medicines are in the ingredients, as long as the batch number is prefixed with Xiao, Zhuang, and Shi, you must not claim any medical effect. If you say during business operations that this herbal ointment with the Xiao brand name can cure athlete's foot, and this herbal ointment with the Shi brand name can cure stomach problems, even if it is really effective, it is considered an operation outside the scope of the business, and you must catch it and get it right.

When I sort out the business scope for my clients, I would specifically advise them that if they only produce herbal products for civilian health care, they should not use the word "medical" to avoid trouble for themselves.； If you really want to start a medical herbal preparation business, don’t just check the national laws and regulations. First, go to the local Municipal Supervision Bureau and the Health Commission window to ask about local pilot policies. The regulatory standards in different places are really different. For example, Guangdong is very liberal in herbal preparations that have the same origin as medicine and food. Many registered herbal soup packets can be labeled with conditioning effects. If they are placed in many northern provinces, they may be suspected of false propaganda.

To put it bluntly, the boundaries of this business scope are constantly adjusted according to regulatory developments and local pilot projects. If you really want to enter this industry, it is much more useful to make more trips to the regulatory authorities and ask more about the practical experience of your peers than to stick to the law.