DEPARTMENT OF HEALTH

(Pharmacy Quality Assurance Commission)

[Filed April 13, 2026, 9:48 a.m.]

Preproposal statement of inquiry was filed as WSR 25-22-008.

Title of Rule and Other Identifying Information: Clarifying conditions for ancillary utilization plans (AUPs) submitted to the pharmacy quality assurance commission (commission) for approval. The commission is proposing to amend WAC 246-945-410 to clarify that only pharmacies may submit an AUP, per RCW 18.64A.040 and 18.64A.060, for approval by the commission to utilize pharmacy ancillary personnel as defined in RCW 18.64A.010(5).

Hearing Location(s): On May 28, 2026, at 1:30 p.m., at the Labor and Industries Building, 7273 Linderson Way S.W., Tumwater, WA 98501; or virtual. To access the meeting, go to https://zoom.us/join or https://us02web.zoom.us/j/86309299195 and use the Webinar ID 863 0929 9195. The access options include one tap mobile: US: +12532158782,,86309299195# or +16699009128,,86309299195#; or phone. Dial (for higher quality, dial a number based on your current location): US: +1 253-215-8782 or +1 669-900-9128 or +1 346-248-7799 or +1 669-444-9171 or +1 386-347-5053 or +1 564-217-2000 or +1 646-558-8656 or +1 646-931-3860 or +1 301-715-8592 or +1 312-626-6799, Webinar ID 861 1495 8466. International numbers available at https://us02web.zoom.us/u/kdLNo6unOZ.

Date of Intended Adoption: May 28, 2026.

Submit Written Comments to: Joshua Munroe, P.O. Box 47852, Olympia, WA 98504-7852, email PharmacyRules@doh.wa.gov, fax 360-236-2901, web https://fortress.wa.gov/doh/policyreview, beginning the date and time of filing, by May 14, 2026, at 11:59 p.m.

Assistance for Persons with Disabilities: Contact Joshua Munroe, phone 360-502-5058, fax 360-236-2901, TTY 711, email PharmacyRules@doh.wa.gov, by May 14, 2026.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: At the June 26, 2025, business meeting, the commission discussed two AUPs submitted by health care entities (HCEs) for approval. The facilities submitting the AUPs cited a passage in WAC 246-945-410(11) that could be interpreted to allow a nonpharmacy entity to submit an AUP based on the use of the term "facility" in that section of rule and how that term is defined in WAC 246-945-405(2). The commission discussed the two AUPs and denied them on the basis of statutory limitations on who can submit AUPs to the commission. Following the discussion, commission staff were tasked with researching the statutes that authorize use of ancillary personnel and AUP submission and approval.

Staff confirmed that RCW 18.64A.040 and 18.64A.060 only allow pharmacies to submit AUPs for commission approval. The commission then decided to initiate rule making to ensure WAC 246-945-410 matches the commission's determination that only pharmacies can utilize ancillary personnel as defined in RCW 18.64A.010(5) and submit AUPs.

Reasons Supporting Proposal: The use of the term "facility" as used in WAC 246-945-410 is not consistent with the AUP submission and approval process as outlined in RCW 18.64A.040 and 18.64A.060. Rule making to amend WAC 246-945-410 by replacing the term "facility" with "pharmacy" is the best method to clarify that only pharmacies may submit a plan for the use of ancillary personnel to the commission for approval.

Statutory Authority for Adoption: RCW 18.64.005, 18.64A.040, and 18.64A.060.

Statute Being Implemented: RCW 18.64A.040, 18.64A.060, and 18.64A.010(5).

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Pharmacy quality assurance commission, governmental.

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 school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is not required under RCW 34.05.328. The proposed rule is exempt under RCW 34.05.328 (5)(b)(iv) because it amends WAC 246-945-410 and clarifies without changing the implementation of the rule who may submit an AUP for approval by the commission to use pharmacy ancillary personnel.

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 only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect.

Explanation of exemptions: The proposed rule amends WAC 246-945-410 and clarifies without changing the implementation of the rule who may submit an AUP for approval by the commission to use pharmacy ancillary personnel.

Scope of exemption for rule proposal:

Hawkins DeFrance, PharmD, Chair

Pharmacy Quality Assurance Commission

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

WAC 246-945-410Facility standards.

A facility must meet the following minimum requirements:

(1) The facility shall be constructed and equipped with adequate security to protect equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.

(2) The facility shall be properly equipped to ensure the safe, clean, and sanitary condition necessary for the proper operation, the safe preparation of prescriptions, and to safeguard product integrity.

(3) The facility shall be staffed sufficiently to allow appropriate supervision, operate safely and, if applicable, remain open during posted hours of operation.

(4) The facility shall be adequately stocked to maintain at all times a representative assortment of drugs in order to meet the pharmaceutical needs of its patients in compliance with WAC 246-945-415.

(5) The facility shall designate a responsible pharmacy manager:

(a) By the date of opening; and

(b) Within ((thirty))30 calendar days of a vacancy.

(6) The facility shall create and implement policies and procedures related to:

(a) Purchasing, ordering, storing, compounding, delivering, dispensing, and administering legend drugs, including controlled substances.

(b) Accuracy of inventory records, patient medical records as related to the administration of controlled substances and legend drugs, and any other records required to be kept by state and federal laws.

(d) Controlling access to legend drugs, including controlled substances.

(7) Prescription drugs must only be dispensed pursuant to a valid prescription as required by WAC 246-945-011.

(8) A drug utilization review of each prescription before dispensing and delivery shall occur except in emergent medical situations, or if:

(a) The drug is a subsequent dose from a previously reviewed prescription;

(b) The prescriber is in the immediate vicinity and controls the drug dispensing process;

(c) The medication delivery system is being used to provide access to medications on override and only a quantity sufficient to meet the immediate need of the patient is removed; or

(d) Twenty-four hour pharmacy services are not available, and a pharmacist will review all prescriptions added to a patient's profile within six hours of the facility opening.

(9) Each drug dispensed and delivered to a patient must bear a complete and accurate label as required by WAC 246-945-015 through 246-945-018. The information contained on the label shall be supplemented by oral or written information as required by WAC 246-945-325.

(10) Access to the drug storage area located within the facility should be limited to pharmacists unless one of the following applies:

(a) A pharmacy intern, or pharmacy ancillary personnel enter under the immediate supervision of a pharmacist; or

(b) A pharmacist authorizes temporary access to an individual performing a legitimate nonpharmacy function under the immediate supervision of the pharmacist; or

(c) The facility has a policy and procedure restricting access to a health care professional licensed under the chapters specified in RCW 18.130.040, and the actions of the health care professional are within their scope of practice.

(11) In accordance with RCW 18.64A.060 prior to utilizing pharmacy ancillary personnel a ((facility))pharmacy shall submit to the commission a utilization plan for pharmacy technicians and pharmacy assistants:

(a) Utilization plan for pharmacy technicians. The application for approval must describe the manner in which the pharmacy technicians will be utilized and supervised, including job descriptions, task analysis or similar type documents that define the duties performed and the conditions under which they are performed, number of positions in each category, as well as other information as may be required by the commission. The commission will be notified of all changes to the utilization plan. A copy of the utilization plan must be maintained in the pharmacy. The utilization plan must comply with WAC 246-945-315 and 246-945-320.

(b) Utilization plan for pharmacy assistants. The application for approval shall list the job title or function of the pharmacy assistant and comply with WAC 246-945-315(3).

(12) A facility's paper prescriptions must be maintained in accordance with WAC 246-945-020 and as follows:

(a) Paper prescriptions for Schedule II drugs must be maintained as a separate file from other prescriptions.

(b) Paper prescriptions for Schedule III, IV, and V drugs must be maintained as a separate file, or maintained in a separate file with prescriptions for noncontrolled legend drugs as allowed under federal law.