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-1529 - Expiration Dating [formerly paragraph 6:207]
Universal Citation: LA Admin Code VI-1529
Current through Register Vol. 50, No. 9, September 20, 2024
A. To assure that the drug product liable to deterioration meets appropriate standards of identity, strength, quality and purity at the time of use, the label of all such drugs shall have suitable expiration dates which relate to the stability test performed on the product.
1. [formerly paragraph 6:207-1] Expiration
dates appearing on the drug product label shall be justified by readily
available data from stability studies such as described in §1527
2. [formerly paragraph 6:207-2] Expiration
dates shall be related to storage conditions stated on the labeling wherever
the expiration date appears.
3.
[formerly paragraph 6:207-3] When the drug is marketed in the dry state for use
in preparing a liquid product, the label shall bear expiration date and
information for the reconstituted product as well as an expiration date for the
product.
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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