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 product.
(1) Expiration dates appearing on the drug labeling shall be justified by readily available data from stability studies such as described in WAC
246-895-110.
(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.
[Statutory Authority: RCW
18.64.005. WSR 92-12-035 (Order 277B), § 246-895-120, filed 5/28/92, effective 6/28/92. Statutory Authority: RCW
18.64.005 and chapter
18.64A RCW. WSR 91-18-057 (Order 191B), recodified as § 246-895-120, filed 8/30/91, effective 9/30/91; Order 133, § 360-46-110, filed 8/4/77.]