What circumstances are not allowed to be declared as preparations for medical institutions?

The situations that may not be declared as preparations for medical institutions are as follows:

1, there are varieties on the market.

2 varieties containing active ingredients that have not been approved by the US Food and Drug Administration.

3. Biological products other than allergen.

4. Traditional Chinese medicine injection.

5. Compound preparation consisting of traditional Chinese medicine and chemical medicine.

6, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs.

7, other preparations that do not meet the relevant provisions of the state.

Preparation of medical institutions refers to the fixed prescription preparation that medical institutions routinely prepare and use for their own use according to the clinical needs of their own units. Preparations in medical institutions have played an important role in history, making up for the shortage of clinical drug varieties and alleviating the contradiction of clinical drug use.

At the same time, many distinctive preparations of medical institutions have gradually developed into new drugs through clinical use, such as Sanjiu Piyanping, Sanjiu Weitai, Zhuanggujiewan and so on. All of them have developed from medical institution preparations to well-known national brand drugs.

Characteristics of preparations in medical institutions:

1, multi-variety, small batch: most kinds of preparations in medical institutions are agreed prescriptions used by medical institutions for a long time, involving various clinical departments of medical institutions, with a wide variety. In order to meet the needs of clinical and scientific research, affected by the scale and scope of application of medical institutions, it is impossible for medical institutions to produce large quantities of preparations, and only medical institutions can prepare them themselves.

2. Short shelf life of varieties: the shelf life of preparations in medical institutions is short, and medical institutions can prepare preparations for clinical use in time to meet the needs of patients.

3. Discontinuity of preparations: The preparation of preparations in medical institutions aims at meeting clinical needs. According to the characteristics and clinical use of preparations in medical institutions, preparations in medical institutions do not need continuous production. The discontinuity of preparations in medical institutions makes it very important and necessary for food and drug supervision and management departments to supervise the preparation conditions, quality management and use management of preparations in medical institutions.