NAC585.540. Date of expiration of drugs.

     1. To ensure that drugs liable to deterioration meet appropriate standards of identity, strength, quality and purity at the time of use, the label of all such drugs must show expiration dates which relate to stability tests performed on the drug.

     2. Expiration dates appearing on the drug labeling must be justified by readily available data from stability studies described in NAC 585.530.

     3. An expiration date must be related to the appropriate storage condition. The condition must be stated on the labeling wherever the expiration date appears.

     4. When a drug is marketed in its dry state for use in preparing a liquid product, the label must bear information concerning the expiration date for the reconstituted product as well as the expiration date for the dry product.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.7-4.7.1.3, eff. 5-15-78]