PREPROPOSAL STATEMENT OF INQUIRY
DEPARTMENT OF HEALTH
(Pharmacy Quality Assurance Commission)
[Filed August 18, 2020, 11:00 a.m.]
Subject of Possible Rule Making: The pharmacy quality assurance commission (commission) is considering a new section in chapter 246-945 WAC for the implementation of SSB 6086, an act relating to increasing access to medications for people with opioid use disorder.
Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 18.64.005
; and SSB 6086 (chapter 244, Laws of 2020).
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: SSB 6086 mandates that the commission adopt rules to establish the minimum standards for opioid use disorder (OUD) medication remote dispensing sites. Consequently, there is no alternative to adopting rules. Current rules related to storing drugs outside of a pharmacy do not adequately cover the minimum standards and exclude certain facilities from having remote dispensing sites, which does not align with the intent of the law. Furthermore, these regulations must be in rule to [be] enforceable.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Every pharmacy that dispenses controlled substances must have a separate registration with the drug enforcement agency (DEA). The FDA-approved OUD medications (e.g. buprenorphine, methadone, and naltrexone) at these remote dispensing sites are controlled substances and will therefore require separate DEA registrations. Any regulations created by this rule making would be in addition to any DEA requirements, and the commission is working closely with the attorney general's office to ensure any state regulations would not conflict.
Process for Developing New Rule: Collaborative.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Lindsay Trant, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-2932, fax 360-236-2321, TTY 711, email PharmacyRules@doh.wa.gov.
Additional comments: Interested parties can sign up for notifications regarding the rule-making process by signing up for GovDelivery at the following address https://public.govdelivery.com/accounts/WADOH/subscriber/new.
August 18, 2020
Tim Lynch, PharmD, MS, FABC, FASHP
Pharmacy Quality Assurance Commission Chair