The business scope of medical herbal therapy preparations includes

The business scope of medical herbal therapy preparations currently covers four major physical categories in China according to regulatory requirements: "finished herbal preparations with approved license numbers, herbal preparations from compliant medical institutions, medical herbal derivatives of the same origin as medicine and food, and external herbal physiotherapy consumables". Some qualified institutions can extend to cover two types of service projects: "customized herbal preparation preparation and clinical use guidance of herbal preparations". The specific boundaries need to be dynamically adjusted based on the local regulatory rules and the institution's own qualifications.

Don’t underestimate the definitions of these few lines. Anyone who has actually passed the qualifications or opened a relevant institution knows that the probability of getting into a trap is much higher than you think.

The first things we come into contact with and the easiest to pass the qualification review are the finished herbal preparations that have the Z prefix of the National Drug Approval or the batch number of Class I or II medical devices. For example, the familiar Yunnan Baiyao aerosol, Jingwanhong burn ointment, and compound grass coral lozenges all fall into this category. As long as ordinary pharmacies have a drug business license, most of them can add these to their business scope, and there is basically no threshold.

Hey, what many people are easily confused about is the operating authority of medical institution preparations (also known as in-hospital preparations). In the past two years, I went to Jiangsu’s Traditional Chinese Medicine Medical Consortium for research, and I saw many community clinics selling herbal eczema ointments and dehumidification ointments prepared in-house under the name of cooperative tertiary-level hospitals. In fact, this is a side effect of the policy - the in-hospital preparations themselves can only be used within the medical institution that applied for the batch number, or circulated within the medical consortium. If ordinary social clinics and pharmacies do not obtain the corresponding entrusted sales qualifications, even the goods obtained from regular hospitals are considered to be operating outside the scope. For example, you can only buy the Qinghua Ointment from Shanghai Longhua Hospital and the Compound Qushi Granules from Beijing Traditional Chinese Medicine Hospital at the hospital headquarters or designated cooperative points. If ordinary pharmacies dare to sell them on the counter, they need to check and confirm.

There is also a boundary issue that has been debated in the industry for several years: Can herbal products that are homologous to medicine and food be included in this business scope?

The attitude of the regulatory side has always been clear: they must have clear medical indications and obtain the corresponding device brand name or drug brand name before they can be included. Ordinary fat sea chrysanthemum tea and herbal autumn pear ointment are food and must not be mixed in. However, many practitioners who open traditional Chinese medicine clinics have a different view: Many consumers come to the clinic for herbal physiotherapy and will buy some health-preserving herbal products. As long as they are clearly marked "non-medical" when selling them and do not promote their efficacy, they can be placed in the same business scenario as medical preparations, and there is no need to be too stuck. At present, the implementation details are indeed different in different places. Last year, I helped a friend from a traditional Chinese medicine clinic in Guangzhou apply for qualifications. The local government allowed the addition of a category of herbal moisturizing tea labeled "assisted in relieving pharyngeal discomfort" into the business scope. However, in a northern province, similar products can only be classified as ordinary food and cannot be classified with medical preparations.

Oh, by the way, there are also herbal physiotherapy consumables for external use, such as moxibustion strips, herbal hot compress packs, and herbal foot bath packs. As long as they obtain the medical equipment brand name, they can also be included in the business scope. Many community stores that provide neck and shoulder physiotherapy will add this item. But it should be noted that ordinary household moxibustion sticks and herbal foot soak bags without batch numbers are daily necessities and are not included.

As for extended services, basically only institutions that have obtained a medical institution practice license and have resident practicing pharmacists can apply. For example, the traditional Chinese medicine departments of some tertiary hospitals can customize and prepare exclusive external herbal ointments for psoriasis patients, adjusting the ratio of comfrey and white fresh bark according to each person's skin lesions. This "customized herbal preparation preparation" service cannot be approved by ordinary small clinics without the corresponding qualifications. There are also some institutions that provide guidance on the use of herbal preparations, such as teaching patients with chronic diseases how to use herbal ointments and how to adjust the frequency of wet compresses. Such services can also be added to the scope of business, but only if they have corresponding medical qualifications.

Finally, I would like to make a practical suggestion. If you really want to add this business scope, don’t just fill in the general list online. First, go to the pharmaceutical and chemical department of the local market supervision bureau to ask for the detailed rules. Not long ago, I met a boss from Shandong who took a locally approved herbal moxibustion liquid of Category 1 equipment and went to Zhejiang to open a branch. However, Zhejiang classified the same product as Category 2 equipment and asked him to replenish his qualifications. He spent three months in vain and lost hundreds of thousands. To put it bluntly, this business scope is more flexible than many people think. The regulatory standards of different places and the qualifications of different institutions will affect the final boundaries of the business scope. It is better to find out the local rules in advance than anything else.

Oh yes, there is another red line to remember: all preparations included in this business scope cannot contain ingredients that are banned by the state, such as aristolochic acid and Guanmutong. Even if you have a historical batch number, you have to remove them all now and cannot touch them.