WAC 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.