Subject of Possible Rule Making: Chapter 246-XXX WAC, the department of health (department) is considering creating a new chapter of rules as required by state law to establish administrative standards and a system of regulation for safe and secure collection and disposal of unwanted medicines through a uniform drug "take-back" program.

Statutes Authorizing the Agency to Adopt Rules on this Subject: ESHB 1047 (chapter 196, Laws of 2018), also known as the "Secure Drug Take Back Act."

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: State law mandates that the department establish a system of regulation for the safe and secure collection and disposal of unwanted medicines through a uniform drug "take-back" program. ESHB 1047 establishes a comprehensive drug take-back program that will be fully financed by the pharmaceutical industry. Rules are necessary to establish a framework for administration, oversight, and enforcement of these drug take-back programs.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The federal Drug Enforcement Administration and the Food and Drug Administration regulate the drugs that will be collected by the programs. The Washington state department of ecology regulates the environmental public safety and hazardous waste disposal. These agencies will be included in the stakeholdering process to the fullest extent possible. Additionally, the pharmacy quality assurance commission regulates the dispensing of drugs, devices, and the practice of pharmacy in Washington state.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Katherine Hoffman, P.O. Box 47852, phone 360-236-2979, TTY 360-833-6388 or 711, email katherine.hoffman@doh.wa.gov.

Additional comments: Interested parties may participate in the development of draft rules prior to a formal proposal by joining the department's interested parties list (GovDelivery) at https://public.govdelivery.com/accounts/WADOH/subscriber/new, attending workshops, and providing input on draft and proposed materials.