Title of Rule and Other Identifying Information: Incorporation by reference of the Drug Supply Chain Security Act (DSCSA). The pharmacy quality assurance commission (commission) is proposing new WAC 246-945-003 for the purpose of incorporating by reference federal statutory language in DSCSA.

Hearing Location(s): On June 26, 2025, at 2:00 p.m., at Capital Region ESD 113, 6005 Tyee Drive S.W., Tumwater, WA 98512; or virtually via Zoom on June 26, 2025, at 9:30 a.m., at https://us02web.zoom.us/j/86309299195 or https://zoom.us/join, Webinar ID 863 0929 9195; or One-tap mobile +12532158782,,86309299195# U.S. (Tacoma), +12532050468,,86309299195# U.S.; or phone +1 253 215 8782 U.S. (Tacoma), +1 253 205 0468 U.S.

Submit Written Comments to: Joshua Munroe, P.O. Box 47852, Olympia, WA 98504-7852, email PharmacyRules@doh.wa.gov, fax 360-236-2260, https://fortress.wa.gov/doh/policyreview/, beginning the date and time of this filing, by June 12, 2025, at 11:59 p.m.

Assistance for Persons with Disabilities: Contact Joshua Munroe, phone 360-502-5058, fax 360-236-2260, TTY 711, email PharmacyRules@doh.wa.gov, by June 19, 2025, at 11:59 p.m.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The commission proposes new WAC 246-945-003 in chapter 246-945 WAC that incorporates by reference the sections of DSCSA that apply to manufacturers, distributors, and other pharmaceutical firms licensed by the commission and under the jurisdiction of DSCSA. The Food and Drug Administration (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.

Reasons Supporting Proposal: Incorporating sections of DSCSA under the commission's jurisdiction allows the commission to implement an interoperable system to allow for the electronic tracing of drug products at the package level across trading partners, and when necessary, allow for verification of products in the drug supply chain, set by the FDA. The proposed incorporation would allow manufacturers, wholesale distributors, pharmacies, and other entities under the jurisdiction of DSCSA to quickly establish the commission's enforcement approach to DSCSA.

Name of Agency Personnel Responsible for Drafting and Implementation: Joshua Munroe, 111 Israel Road S.E., Tumwater, WA 98501, 360-502-5058; Enforcement: Marlee O'Neill, 111 Israel Road S.E., Tumwater, WA 98501, 360-480-9108.

A cost-benefit analysis is not required under RCW 34.05.328. The proposed rule is exempt from a cost-benefit analysis as it utilizes the exception rule-making process due to it "adopting or incorporating by reference without material change federal statutes or regulations" per RCW 34.05.310 (4)(c).

This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal:

Is exempt under RCW 19.85.025(3) as the rules are adopting or incorporating by reference without material change federal statutes or regulations, Washington state statutes, rules of other Washington state agencies, shoreline master programs other than those programs governing shorelines of statewide significance, or, as referenced by Washington state law, national consensus codes that generally establish industry standards, if the material adopted or incorporated regulates the same subject matter and conduct as the adopting or incorporating rule.

Explanation of exemptions: The sections of Title 21 U.S.C. listed above are incorporated by reference by the commission without material changes to the language.

(1) The commission adopts and incorporates 21 U.S.C. Sec. 360eee, Sec. 360eee-1, and Sec. 360-eee4 (a) and (c) of the Drug Supply Chain Security Act of 2013 (127 Stat. 587; 21 U.S.C. Sec. 360eee et seq.) in effect as of August 22, 2024, by reference.

(2) Copies of the reference material listed in subsection (1) of this section are available for public inspection at the commission's office at Department of Health, Town Center 2, 111 Israel Road S.E., Tumwater, WA 98501. Requestors may also access copies at https://uscode.house.gov/.