Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part III - Prevention of Diseases
Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS
Section 25.22 - Expiration dating
Current through Register Vol. 54, No. 44, November 2, 2024
To 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.
