WSR 22-21-062

POLICY STATEMENT

DEPARTMENT OF HEALTH

[Filed October 12, 2022, 4:21 p.m.]

NOTICE OF ADOPTION OF A POLICY STATEMENT

Title of Policy Statement: Regulatory Standards Applicable to Manufacturers and Wholesalers of Dialysis Devices and Legend Drugs for Home Dialysis. P008.

Issuing Entity: Pharmacy quality assurance commission.

Subject Matter: This policy clarifies expectations set by the pharmacy quality assurance commission for manufacturers and wholesalers of commercially-available dialysate and dialysis devices to comply with sections of rule related to existing statutes amended by SHB 1675 (chapter 23, Laws of 2022).

Effective Date: June 9, 2022.

Contact Person: Marlee B. O'Neill, executive director, pharmacy quality assurance commission, Washington state department of health, 360-236-4700, WSPQAC@doh.wa.gov.