Subject of Possible Rule Making: WAC 246-480-010, 246-480-070, 246-480-080, and 246-480-990 within chapter 246-480 WAC, Drug take-back program. The department of health (department) is considering rule making to implement 2SHB 1161 (chapter 155, Laws of 2021). Rule making will consider aligning existing rules with 2SHB 1161 and adopting other amendments necessary to regulate the state drug take-back program, also known as the "safe medication return" program. Amendments may include clarifying how multiple program operators participate in the drug take-back program, setting fees, and other changes as appropriate.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The department is considering amending WAC 246-480-010, 246-480-070, 246-480-080, and 246-480-990 to implement recent legislation. Rule making is necessary to align existing rule with statutory changes made by 2SHB 1161. The bill makes several amendments to the drug take-back program including: (1) Allowing multiple program operators, (2) allowing new potential operators to apply periodically, (3) requiring a proposal review fee for applications, (4) requiring coordination between approved program operators, (5) referencing the department's authority to adopt rule and set fees, and (6) other changes. The department will consider rule amendments to implement 2SHB 1161 and to support the consistent regulation and operation of the statewide drug take-back program.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The federal Drug Enforcement Administration (DEA) and the Food and Drug Administration regulate the drugs that are collected by safe medication return programs. The Washington state department of ecology regulates environmental public safety and hazardous waste disposal. These agencies may participate in the rule-making process at their discretion. Additionally, the pharmacy quality assurance commission (PQAC) regulates the practice of pharmacy and the dispensing of drugs and devices in Washington state. PQAC will be sent GovDelivery notices as the rule-making process moves forward.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Mary Kellington, P.O. Box 47852, Olympia, WA 98504, phone 360-236-2988, TTY 711, email mary.kellington@doh.wa.gov.

Additional comments: Rule-making notices will be delivered via GovDelivery. To receive notices, interested persons may sign up for any or all of the lists. Please go to https://public.govdelivery.com/accounts/WADOH/subscriber/new. After signing in, please click open the box labeled "Health Systems Quality Assurance." Next click open the box labeled "Health Professions." From there, you may check the box next to one or more of the professions listed. Notices regarding this rule making will be sent to the "Safe Medication Return" list.