WSR 15-16-024 PREPROPOSAL STATEMENT OF INQUIRY DEPARTMENT OF HEALTH (Pharmacy Quality Assurance Commission) [Filed July 27, 2015, 9:07 a.m.]
Subject of Possible Rule Making: WAC 246-869-040 and 246-869-190, pharmacy inspections, the pharmacy quality assurance commission (commission) is considering updating the pharmacy inspections process.
Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 18.64.005.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: Pharmacy inspections are a vital part of ensuring that pharmacies practice in a manner that protects the health, safety, and welfare of the people of Washington. The pharmacy inspection rules were last updated in 1992. Currently, inspections use a point-based system to evaluate pharmacy's [pharmacies'] compliance with the federal and state rules. This process for inspections has become outdated and has caused frustration among both licensees and inspectors. Additionally, the practice of pharmacy has dramatically changed since 1992. With changes in the practice of pharmacy, the pharmacy inspection process needs to be updated.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Department of social and health services, department of corrections, and Federal Drug Enforcement Administration will be invited to participate as stakeholders in the rule-development process.
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 Brittany Mahugh, Policy Analyst, Department of Health, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504-7852.
July 27, 2015
Chris Humberson, R.Ph.
Executive Director
Pharmacy Quality Assurance Commission
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