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. 1. [formerly paragraph 6:206-1] determined by reliable, specific test methods;
2. 2. [formerly paragraph 6:206-2] determined on products in the same container closure system in which they are marketed;
3. 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. 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.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:601 et seq.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1255 (June 2002).