WSR 18-01-124

PREPROPOSAL STATEMENT OF INQUIRY

[Filed December 19, 2017, 2:18 p.m.]

Subject of Possible Rule Making: Chapter 246-XXX WAC, the pharmacy quality assurance commission (commission) is considering reevaluating the parameters around exercising its regulatory authority, specifically functions of the commission, and other general provisions that apply to the regulation of the practice of pharmacy. The commission will reevaluate current standards around its functions as a regulatory body, and will consider reorganizing standards in a new chapter or chapters to address any changes identified as needed.

Statutes Authorizing the Agency to Adopt Rules on this Subject: Chapters 18.64, 18.64A, 69.40, 69.41, 69.50, and 69.51 RCW.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The commission is responsible for setting the standards and requirements for the practice of pharmacy in Washington state. A crucial part of the commission's role in regulation is how it implements and functions under the rules and statutes that apply to the practice of pharmacy. A 2017 review of all of the commission's rules has shown a majority are out-of-date, and sixty percent of the commission's thirty-four chapters of WAC have not been amended since the 1980s. Health care delivery and the role of pharmacists and other pharmacy personnel has changed dramatically over the last thirty years, and outdated rules have led to inconsistent application and interpretation of rules. Following the review, the commission determined it needed to reexamine and look to modernize the standards around its regulatory framework or other general provisions applicable to the pharmacy practice as part of an overhaul of all the outdated rules. The rules require modernization to better align with current pharmacy practice, trends and industry standards. Reexamining the current standards may involve reorganizing or replacing standards across multiple existing sections or chapters of WAC.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The Drug Enforcement Administration will need to be kept up to date throughout the rule making process to ensure they are apprised of any requirement changes regarding controlled substances.

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 by contacting Tracy West, P.O. Box 47850, Olympia, WA 98504-7850, phone 360-236-4988, TTY 360-833-6388 or 711, email tracy.west@doh.wa.gov.

Additional comments: Interested parties can sign up for updates through GovDelivery on all commission rule projects. Additional updates will be posted regularly on the commission's rules in progress web site.

December 19, 2017

Tim Lynch, PharmD, MS, Chair

Pharmacy Quality Assurance Commission