WSR 15-22-073

PREPROPOSAL STATEMENT OF INQUIRY

[Filed November 2, 2015, 1:54 p.m.]

Subject of Possible Rule Making: Chapter 246-801 WAC, Donated prescription drugs and supplies program, the department of health is considering new rules establishing forms and procedures to verify the eligibility and prioritization of patients seeking to receive donated prescription drugs and supplies. The rules would also address disclosure to those receiving donated prescription drugs that the drugs have been donated and redistributed.

Statutes Authorizing the Agency to Adopt Rules on this Subject: Chapter 69.70 RCW.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: RCW 69.70.060 requires the department to engage in rule making to establish forms and procedures to accomplish two things: (1) Verify the eligibility of patients and prioritize those patients seeking to receive donated drugs and supplies, and (2) inform recipients that the drugs they are receiving have been donated for redistribution.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The United States Food and Drug Administration will be consulted with as needed.

Process for Developing New Rule: Collaborative rule making.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication. Stakeholders will be invited to participate in rule-writing workshops and provide input throughout the rule-making process. Interested parties can sign up to receive information, updates, or provide comments to the department by contacting Andy Fernando, Rules and Legislation Manager, at andres.fernando@doh.wa.gov or by mail to Andy Fernando, Department of Health, P.O. Box 47852, Olympia, WA 98504-7852.

November 2, 2015

John Wiesman, DrPH, MPH

Secretary of Health