What are the requirements and standards for the business scope of medical herbal therapy preparations?

First, the business entity must hold access qualifications issued by the corresponding regulatory authorities, and second, the preparations sold must have legal marketing/recording certificates. Both are indispensable. Anyone who skirts the boundaries of "medicine and food have the same origin" and operates beyond the scope will be fined and confiscated, and may be held criminally liable.

I ran into a similar pitfall two years ago when I was helping a friend who opened a traditional Chinese medicine clinic to obtain business qualifications. At that time, he felt that there were licensed traditional Chinese medicine practitioners in the clinic who had been registered for three years. It was normal for him to make herbal ointments based on ancient recipes and give them to patients. He also planned to sell them at the front desk. As a result, When the Municipal Supervision Bureau came to verify the qualifications, it immediately stopped it, saying that if this kind of herbal preparation made in the hospital did not go through the registration process of the Provincial Administration of Traditional Chinese Medicine and the Food and Drug Administration, it would not be compliant even if it was only used for medical patients, let alone included in the scope of business for sale to outsiders.

If you are engaged in retail sales, such as community pharmacies and compliant traditional Chinese medicine clinics, you must first clearly add "retail sales of traditional Chinese medicine pieces/medical preparations" in the business scope of the business license, and obtain a "Pharmaceutical Business License" issued by the Food and Drug Administration Department. If the medical herbal preparations sold are managed as prescription drugs, a licensed pharmacist must be on duty to verify the prescription before they can be sold. If it is a Class B over-the-counter drug, the purchase voucher and product registration certificate must be placed in a conspicuous place for consumers to inspect. The requirements for wholesale are even stricter. In addition to having complete qualifications, the warehousing must also fully comply with the requirements of the quality management regulations for pharmaceutical operations. Temperature and humidity must be monitored 24 hours a day. Many ingredients of herbal preparations are unstable and they are afraid of moisture and sunlight. If the warehousing is not up to standard, the medicine will be damaged and the effect will be small. If an adverse reaction occurs, the operator must bear full responsibility.

There is still a fuzzy area that has been debated for a long time in the industry, which is whether health centers that specialize in physical therapy and health care can operate such preparations? One group of people believes that as long as the preparation itself is a compliant medical or consumer brand, and the health center has the corresponding health license, it can sell it. The other group believes that as long as the product clearly claims to have therapeutic effects, no matter what brand name it is, it must comply with the pharmaceutical business requirements. There are indeed differences in the actual implementation of standards across regions. The Jiangsu and Zhejiang regions I came into contact with are stricter. As long as the product description mentions "treating certain types of diseases", even if it is purely herbal ingredients, the business entity must hold a pharmaceutical business qualification. Many health care centers in the lower market sell herbal patches and hot compress packs with registered mechanical brands, but they have not been judged to be out of scope. If you are not sure, it is best to ask the Pharmaceutical and Chemical Supervision Section of the local Municipal Supervision Bureau in advance. Don’t wait until the store is opened to make rectifications, which will delay things.

There is another requirement that many operators tend to overlook, which is that the purchase and sale ledger of this type of preparation must be kept for at least 5 years. The source of purchase, sales destination, corresponding batch, and inspection certificate must be clearly sorted out. Last year, we had a local chain drugstore selling A herbal cough syrup was randomly inspected and found to be unqualified because the ledger was complete. The problem was quickly traced to the batch problem of the upstream production company, which was not jointly and severally liable. If the ledger was incomplete, the fine alone would start in six figures, and in serious cases, the business qualification would be revoked. By the way, you can’t make random claims when doing business. Even if the product is fully compliant, if the promotional content exceeds the registered indications, it is considered false advertising. Not long ago, an e-commerce anchor brought a medical herbal eczema cream and boasted that it could cure urticaria and allergic dermatitis. In the end, not only the anchor was fined 200,000, but the operator who authorized him to bring the goods was also fined for failing to fulfill its publicity and audit obligations. This is also considered an invisible red line in the scope of business, so don’t take it seriously.