La. Admin. Code tit. 51 § VI-1529

Current through Register Vol. 50, No. 9, September 20, 2024

Section VI-1529 - Expiration Dating [formerly paragraph 6:207]

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.

La. Admin. Code tit. 51, § VI-1529

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

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