WSR 16-16-025

PREPROPOSAL STATEMENT OF INQUIRY

[Filed July 22, 2016, 3:16 p.m.]

Subject of Possible Rule Making: Chapter 246-873A WAC (new) and chapter 246-873 WAC, Pharmacy hospital standards, the pharmacy quality assurance commission (commission) is considering establishing standards supporting the regulatory, inspection, and investigation of pharmacy services provided in individual practitioner offices and multi-practitioner clinics owned and operated by a hospital based on the level of risk and the type of pharmacy services provided at a particular location.

Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 18.64.043 as amended by SSB 6558 (chapter 118, Laws of 2016), and RCW 18.64.005.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: Currently, RCW 18.64.043 allows hospital pharmacy licenses to include any individual practitioner's office or multipractitioner clinics owned and operated by a hospital, and identified by the hospital on the pharmacy application or renewal, but no supporting rules providing specific information regarding the licensing process were ever implemented. SSB 6558 directs the commission to provide clear and specific standards supporting the regulatory, inspection and investigation of these associated licensed clinic locations based on the level of risk and the type of pharmacy services provided at a particular location.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The Drug Enforcement Administration (DEA) enforces the controlled substances laws and regulations of the United States. The potential exists that controlled substances could be transferred and stored at these hospital pharmacy associated clinics. The commission will need to coordinate information with the DEA to keep them informed of clinic sites in possession of controlled substances for DEA registration purposes. Other regulator [regulatory] bodies that provide guidance and oversight for drug handling and compounding practices include the Center for Disease Control, the Food and Drug Administration and the United States Pharmacopeia will be valuable resources for these new rules.

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 commission at WSPQAC@doh.wa.gov or by contacting Rich Cieslinski R.Ph., Rules Coordinator, Department of Health, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504-7852.

July 22, 2016

Steven Saxe, R.Ph., FACHE

Executive Director

Pharmacy Quality Assurance Commission