Current through Register Vol. 54, No. 24, June 15, 2024
Section 25.22 - Expiration datingTo assure that drug products liable to deterioration meet 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 stability tests performed on the products.
(1) Expiration dates appearing on the drug labeling shall be justified by readily available data from stability studies such as described in § 25.21 (relating to stability).(2) Expiration dates shall be related to appropriate storage conditions stated on the labeling wherever the expiration date appears.(3) When the drug is marketed in the dry state for use in preparing a liquid product, the labeling shall bear expiration information for the reconstituted product as well as an expiration date for the dry product.