DEPARTMENT OF HEALTH

(Pharmacy Quality Assurance Commission)

[Filed December 2, 2024, 1:54 p.m., effective January 2, 2025]

Effective Date of Rule: Thirty-one days after filing.

Purpose: Expanding access to drugs stored outside of the pharmacy by unlicensed health care facility staff. The pharmacy quality assurance commission (commission) is adopting amendments to WAC 246-945-455 to allow access to drugs stored outside of the pharmacy by unlicensed staff in health care facilities for the purposes of supply chain management.

Citation of Rules Affected by this Order: Amending WAC 246-945-455.

Statutory Authority for Adoption: RCW 18.64.005, 69.41.075, and 69.50.301.

Adopted under notice filed as WSR 24-17-006 on August 8, 2024.

A final cost-benefit analysis is available by contacting Haleigh Mauldin, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-890-0720, fax 360-236-2260, TTY 711, email PharmacyRules@doh.wa.gov, website https://fortress.wa.gov/doh/policyreview/.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 1, Repealed 0.

Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.

Date Adopted: December 2, 2024.

Hawkins DeFrance, PharmD, Chair

Pharmacy Quality Assurance Commission

AMENDATORY SECTION(Amending WSR 20-12-072, filed 6/1/20, effective 7/1/20)

WAC 246-945-455Drugs stored outside of the pharmacy.

(1) In order for drugs to be stored in a designated area outside the pharmacy including, but not limited to, floor stock, in an emergency cabinet, in an emergency kit, or as emergency outpatient drug delivery from an emergency department at a registered institutional facility, the following conditions must be met:

(a) Drugs stored in such a manner shall remain under the control of, and be routinely monitored by, the supplying pharmacy;

(b) The supplying pharmacy shall develop and implement policies and procedures to prevent and detect unauthorized access, document drugs used, returned and wasted, and regular inventory procedures;

(c) Access to drugs stored in a designated area outside of the pharmacy must be limited to health care professionals licensed under the chapters specified in RCW 18.130.040 acting within their scope, and nursing students as provided in WAC 246-945-450, except as provided in subsection (2) of this section;

(d) The designated area is appropriately equipped to ensure security and protection from diversion or tampering; and

(e) The designated area must be located in a facility ((is able))licensed or otherwise authorized by law to possess and store drugs.

(2) An unlicensed employee or contractor of the receiving facility may access drugs stored in the designated area if all of the following are met:

(a) The unlicensed employee or contractor is acting within their scope of employment or contract;

(b) The unlicensed employee or contractor is accessing drugs for the purpose of supply chain management at the receiving facility;

(c) The unlicensed employee or contractor is only accessing drugs listed in a policy and procedure that is readily retrievable by the supplying pharmacy; and

(d) The unlicensed employee or contractor is not accessing controlled substances.

(3) For nursing homes and hospice programs an emergency kit or supplemental dose kit must comply with RCW 18.64.560.