Of a labeled date indicating stability after reconstitution or lack of studies to support the appropriateness of that date.
Expiration dating and stability testing for human drug products
(5) testing of drug products for reconstitution at the time of dispensing (as directed in the labeling) as well as after they are reconstituted.
Requirements for expiration dating and stability testing
The written program shall be followed and shall include:(1) sample size and test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability;.
Where data from accelerated studies are used to project a tentative expiration date that is beyond a date supported by actual shelf life studies, there must be stability studies conducted, including drug product testing at appropriate intervals, until the tentative expiration date is verified or the appropriate expiration date determined.
The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates.
Accelerated studies, combined with basic stability information on the components, drug products, and container-closure system, may be used to support tentative expiration dates provided full shelf life studies are not available and are being conducted.
., less than three) employed as the basis for either confirming a tentative expiration date or establishing the long-term stability of the product.