WSR 10-11-023

PREPROPOSAL STATEMENT OF INQUIRY

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed May 10, 2010, 10:15 a.m. ]

Subject of Possible Rule Making: Chapter 246-873 WAC, Pharmacy -- Hospital standards.

Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 18.64.005, 18.64A.030, and 18.64A.040.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: Chapter 246-873 WAC, Pharmacy -- Hospital standards, have not been revised since 1992. Hospital pharmacy practice during this time period has changed dramatically. The department has identified references, definitions and terms in the rules that are outdated. Key portions of the rules may be revised in order to accurately reflect: (1) Current clinical practices; (2) new national requirements for sterile compounding; (3) electronic medication ordering practices; (4) use of electronic records; (5) emergency outpatient pharmacy practices; and (6) new technologies.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The Food and Drug Administration and the Drug Enforcement Administration are the primary federal agencies that regulate the practice of pharmacy. Most hospitals and their pharmacies undergo voluntary regulation by the Joint Commission. The United States Pharmacopeia (USP) sets many standards for medications and their storage. In 2004 the USP issued its first enforceable standard, USP 797 Sterile Compounding. The board of pharmacy utilizes requirements and procedures from all of these organizations. When federal requirements vary from state requirements, the board follows the strictest rule. Areas of less clarity are resolved through collaboration.

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. The department will convene a series of rule workshops and set up a dedicated listserv. Interested parties can receive information on how to participate in the updating of the rule by contacting Tim Fuller, Pharmacist Consultant, Health Professions and Facilities, 310 Israel Road S.E., Tumwater, WA 98501-7852, e-mail tim.fuller@doh.wa.gov, phone (360) 236-4827, fax (360) 236-2901. The department will also notify all licensees and organizations who have expressed an interest in rule-making activities.

May 10, 2010

Susan Teil Boyer

Executive Director

Washington State Code Reviser's Office