LAC 51:VI.1527. Stability [formerly paragraph 6:206]

A. There shall be assurance of the stability of the finished drug products. This stability shall be: 1. [formerly paragraph 6:206-1] determined by reliable, specific test methods; 2. [formerly paragraph 6:206-2] determined on products in the same container closure system in which they are marketed; 3. [formerly paragraph 6:206-3] determined on any dry drug product that is to be reconstituted at the time of dispensing (as directed in its labeling) as well as on the reconstituted product; 4. [formerly paragraph 6:206-4] recorded and maintained in such a manner that the stability data may be utilized in establishing product expiration dates.