Section 246-895-120. Expiration dating.

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.]

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.

Rules

246-895-110,