Louisiana Administrative Code
Title 51 - PUBLIC HEALTH-SANITARY CODE
Part VI - Manufacturing, Processing, Packing and Holding of Food, Drugs and Cosmetics
Chapter 15 - Current Good Manufacturing Practices in the Manufacture of Drugs
Section VI-1527 - Stability [formerly paragraph 6:206]
Universal Citation: LA Admin Code VI-1527
Current through Register Vol. 50, No. 9, September 20, 2024
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.
AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:601 et seq.
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