What are the temperature requirements for ambient and cool areas in the Conditions for the Storage of Pharmaceuticals?

The room temperature area needs to be within 0-30℃, and the cool storage needs to be below 20℃.

Drugs should be stored in the appropriate library according to the temperature and humidity requirements of the drugs, drug companies should maintain a constant temperature of all types of drug storage. For each type of drugs, should be based on the requirements of the storage conditions of the drug labeling, were stored in a cold storage (2-10 ℃), cool storage (below 20 ℃) or room temperature library (0-30 ℃), the relative humidity of each library should be maintained between 45% -75%.

The temperature range required by the establishment of the cold storage, cool storage and room temperature library, should be used to ensure the quality of medicines, in line with the principle of the prescribed storage conditions for medicines, scientific and reasonable settings, that is, the operation of the drugs labeled should be stored in what temperature and humidity, should be set up in the corresponding temperature and humidity range of the warehouse. Such as the operation of drugs labeled as 15-25 ℃ storage, should be set up 15-25 ℃ constant temperature warehouse.

For the identification of more than two different temperature and humidity storage conditions of the drugs, generally should be stored in a relatively low-temperature library, such as a drug labeled storage conditions: 20 ℃ below the expiration date of 3 years, 20-30 ℃ expiration date of 1 year, the drug should be stored in a cool library.

Expanded information

Chinese herbal medicines, Chinese medicine tablets storage: should be based on the nature of Chinese herbal medicines, Chinese medicine tablets set up the appropriate storage warehouse, reasonable control of temperature and humidity conditions. For varieties that are easy to be moth-eaten, mildewed, oiled and discolored, sealed, dry, cool and clean warehouses should be set up; for varieties that operate in smaller quantities and are easy to be discolored, volatilized and melted, storage equipment that protects from light and heat, such as refrigerators and freezers, should be equipped.

For poisonous and narcotic Chinese medicines should be special, special accounts, special library (or cabinet), double lock storage.

Aiming at different storage conditions, combined with the "Drug Business Quality Management Code" requirements, in the daily work, increase the importance of drug storage and maintenance of custody, strengthen the sense of responsibility, familiar with the physical and chemical characteristics of various drugs, to take a scientific and rational approach to the storage of medicines is to ensure that the quality of medicines is necessary to ensure that the necessary measures to control the quality of medicines are also drugs to play the essence of the properties of the treatment of diseases to save people's lives is necessary. It is also a prerequisite for medicines to fulfill their essential properties of curing diseases and saving lives.

Reference:

Baidu Encyclopedia-Drug Storage