WSR 25-19-024

PERMANENT RULES

DEPARTMENT OF HEALTH

(Pharmacy Quality Assurance Commission)

[Filed September 5, 2025, 7:42 a.m., effective October 6, 2025]

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

Purpose: The pharmacy quality assurance commission (commission) adopted new WAC 246-945-003 that incorporates by reference the sections of the Drug Supply Chain Security Act (DSCSA) that apply to manufacturers, distributors, and other pharmaceutical firms licensed by the commission and under the jurisdiction of DSCSA. FDA completed updates to DSCSA in 2023, but has allowed a "stabilization period" for entities to come into compliance. The purpose of the proposal is to align the commission's regulatory language with the updates to the federal statutory language of DSCSA.

The incorporated federal sections include definitions pertaining to DSCSA (21 U.S.C. Section 360eee), the standards, exemptions, and other requirements for the "interoperable exchange of transaction information, transaction history, and transaction statements" (21 U.S.C. Section 360eee-1), product tracing and other requirements to ensure uniform national policy (21 U.S.C. Section 360eee-4(a)), and exceptions for state-level requirements (21 U.S.C. Section 360eee-4(c)). The anticipated effect of incorporating these sections by reference is to facilitate compliance with federal law and clarify how the commission will enforce DSCSA.

Citation of Rules Affected by this Order: New WAC 246-945-003.

Statutory Authority for Adoption: RCW 18.64.005.

Adopted under notice filed as WSR 25-11-064 on May 19, 2025.

Number of Sections Adopted in Order to Comply with Federal Statute: New 1, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's own Initiative: New 1, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 1, Amended 0, Repealed 0.

Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 0, Repealed 0.

Date Adopted: September 5, 2025.

Hawkins DeFrance, PharmD, Chair

Pharmacy Quality Assurance Commission

RDS-6250.1