Comparative Analysis of In-use Period after First Opening or Reconstitution of European Union Imported Sterile Products and Domestic Sterile Products in Our Hospital / 中国药师

Objective: To provide reference and suggestions for improving the in-use period information of sterile products after first opening or reconstitution in China. Methods: The package inserts of sterile products in our hospital were investigated. The sterile products needed to be reconstituted before use and with multiple-dose package were selected. The in-use period information of European imported sterile products and domestic sterile products were comparatively analyzed. Results: The presentation rate of in-use period in the package inserts of domestic sterile products was 32. 25% , which was less than 55. 56% of the other imported sterile products, and significantly less than 93. 55% of European imported sterile products. Conclusion: The relevant content of in-use period of sterile products after first opening or reconstitution is supplemented relatively late in China's stability testing guidance for drug substances and products, moreover, the specific technical proposals are absent. It is suggested that the drug administrative department and its techni-cal supportive agencies should improve the relevant guidance and guide pharmaceutical research enterprises and manufacturing enterpri-ses to carry out in-use stability studies, furthermore, gradually improve the relevant in-use period information in package inserts.

Compliance Policy for Expiration Date of Repackaged Drugs in America and Its Enlightenments for China / 中国药房

OBJECTIVE:To provide references and suggestions for expiration date management of dismounted drugs in China.METHODS:The main contents about compliance policy for expiration date of repackaged drugs in America were summarized.The current situation and problems of expiration date management of dismounted drugs in China were analyzed to provide suggestions for standardizing expiration date management of dismounted drugs in China.RESULTS & CONCLUSIONS:The compliance policy for expiration date of repackaged drugs in America contain determination principle of expiration date of repackaged drugs,repackaged container standard,etc.In contrast,the expiration date management of dismounted drugs in China is lack of specific standards and requirements;major issues are as follows as the concept of expiration date of dismounted drugs is ambiguous and container management is not standardized.It is suggested that relevant departments can refer to compliance policy for expiration date of repackaged drugs in America,define the method of determining the expiration date of the dismounted drugs,and standardize the standards and management of packaging containers so as to standardize expiration date management of dismounted drugs in China practically.