PDFWAC 246-945-090
Home dialysis programs, manufacturers, and wholesalers—Legend drugs and dialysis devices.
Pursuant to RCW 18.64.257 and 69.41.032, a medicare-approved dialysis center, a facility operating a medicare-approved home dialysis program, a manufacturer, or a wholesaler may sell, deliver, possess, or dispense directly to its home dialysis patients, in case or full shelf lots, and if prescribed by a practitioner, the following:
(1) Legend drugs:
(a) Sterile heparin, 1000 u/mL, in vials;
(b) Sterile potassium chloride, 2 mEq/mL, for injection;
(c) Commercially available dialysate; and
(d) Sterile sodium chloride, 0.9%, for injection in containers of not less than 150 mL.
(2) Dialysis devices:
(a) Class II medical devices that are manufactured and marketed in compliance with the Federal Food, Drug, and Cosmetic Act and indicated for acute and chronic dialysis therapy in the home; and
(b) Related supplies and accessories of the dialysis device.
[Statutory Authority: RCW 18.64.005, 18.64.257, and 69.41.032. WSR 25-07-093, s 246-945-090, filed 3/18/25, effective 4/18/25. Statutory Authority: RCW 18.64.005, 18.64.080, 18.130.075, 18.64.043, 18.64.044, 18.64.045, 18.64.046, 18.64.370, 18.64.460, 69.50.310, 18.64.011, 18.64.245, 18.64.470, 18.64.255, 18.64.205, 18.64.253, 18.64.410, 18.64.500, 18.64.590. WSR 20-12-072, § 246-945-090, filed 6/1/20, effective 7/1/20.]