Rule-Making Activity

The Pharmacy Quality Assurance Commission is considering amending WAC 246-945-507 to add certain intramammary antibiotic formulation drugs to the list of approved legend drugs in response to a petition from a veterinarian at the Washington Department of Fish and Wildlife (WDFW).

The Pharmacy Quality Assurance Commission is considering amending WAC 246-945-155, WAC 246-945-156, and adding a new section to chapter 246-945 WAC. These changes would grant renewal extensions to pharmacy interns and would extend temporary pharmacy intern practice permits for spouses of military personnel in accordance with Second Substitute House Bill 1009 (chapter 165, Laws of 2023).

The Department of Health is considering establishing a new chapter of rules, chapter 246-819 WAC, for the dental therapist profession to implement Engrossed Substitute House Bill (ESHB) 1678 (Chapter 460, Laws of 2023).

The Department of Health (department) is considering amending chapter 246-790 WAC to increase flexibility in allowed vendor types and update program requirements for vendors. The department is also considering amendments to the Participant Compliance rules to reflect virtual service options.

Jocelyn W. Jones
360-236-3020

Stuart Glasoe
360-236-4111

The Pharmacy Quality Assurance Commission is considering creating a new section(s) in chapter 246-945 WAC related to the regulation of the practices of “white bagging” and “brown bagging” or any other transfer of a prescription or drug for the purpose of re-dispensing or subsequent administration to a patient. Concerns have been raised over ensuring the integrity and quality of these medications is maintained if such practices are used by prescribers, hospitals, or patients because these practices can create an unknown chain of custody.

Clarifying terms and information about prescription history for the PMP. The Department of Health (department) is considering clarifying that prescribers can request the history of prescriptions they have written. The department is considering changes to WAC 246-470- 010, 246-470-030, and 246-470-050 and potentially other related sections in chapter 246-470 WAC to help clarify rules including terms and definitions relating to the Prescription Monitoring Program.

The Pharmacy Quality Assurance Commission is considering amending WAC 246-945-345 and potentially establishing a new section in chapter 246-945 WAC to clarify the expectation of pharmacies related to prescription transfers upon patient request. Other amendments to facilitate the timely transfer of prescription may also be considered.

The Board of Physical Therapy is considering amendments to update initial licensure and endorsement requirements in consideration of Second Substitute House Bill (2SHB) 1724, (chapter 425, Laws of 2023). The board will also consider making general updates to the licensing and endorsement process, examine the jurisprudence examination requirement, and review for housekeeping changes.

The Department of Health is considering updates to rules regarding acute care and private psychiatric hospital fees to address funding needs under WAC 246-322-990. An update may be necessary to adequately fund the hospital inspection, investigation, and licensing programs to protect patients.

The Department of Health is considering changes to requirements for adult elective PCI programs in response to a rulemaking petition. The petition requests amendment of WAC 246-310-720(2), to eliminate the requirement that existing PCI programs in the planning area must meet the minimum volume standard before a new elective PCI program may be approved. The department will also consider amendments to other PCI rules, as part of this rule project.

The Veterinary Board of Governors is considering updates and revisions to WAC 246-935-050 animal health care tasks, WAC 246-935-040 responsibilities of a Veterinarian supervising a licensed Veterinary Technician or unregistered assistant, WAC 246-935-010 definitions (Veterinary Technicians), and WAC 246-937-010 definitions (registered Veterinary Medication Clerks).

The Department of Health is considering establishing chapter 246-385 WAC as a new chapter of rules to set inspection and operational standards for private detention facilities, health and safety standards for detained persons, and issuance of civil penalties pursuant to Second Substitute House Bill 1470 (2SHB 1470), chapter 419, Laws of 2023.

The Washington State Board of Health (Board) is considering adding Guanidinoacetate methyltransferase deficiency (GAMT) and Arginase 1 deficiency (ARG1-D) to the list of mandatory conditions for newborn screening conducted by the Department of Health (Department).

The Board has the authority under RCW 70.83.050 to define and adopt rules for screening Washington-born infants for hereditary conditions. WAC 246-650-010 defines the conditions, and WAC 246-650-020 lists the conditions for which all Washington-born newborns are to be screened. GAMT deficiency and ARG1-D are rare inherited metabolic conditions that can result in severe disability and in some cases death if not detected and treated early. Early diagnosis of GAMT deficiency and ARG1-D through newborn screening is essential to save lives and to improve the quality of life for impacted infants and their families.

To be added to the listserv for notifications regarding this rulemaking, email Molly.Dinardo@sboh.wa.gov with the subject line "Newborn Screening – GAMT & ARG1-D."

Amending WAC 246-840-010, 246-840-340, 246-840-342, and other related sections in chapter 246-840 WAC. The Washington State Board of Nursing is considering amendments to education requirements for ARNP licensure in response to the Joint Administrative Rules Review Committee’s (JARRC) recommendation.

The Washington State Board of Health is considering amending the auditory screening sections of chapter 246-760 WAC, Auditory and Visual Standards – School Districts, to align with current national evidence-based practices and assess potential options regarding whether to include otoacoustic emission (OAE) screening technology in the Board’s rules. The Board may also consider other technical or editorial changes as needed.

The Department of Health is considering a chapter review to reorganize sections and amend rules regarding J-1 Physician Visa waivers. The department is exploring updates to help meet the greatest needs across Washington State. The department will also look for increased clarity in the organizational structure, application criteria, and requirements for letters of support.

The Department of Health is considering adding a new section of rule to address the medication administration requirements for the medical assistant-registered credential to align with recent legislation and considering updating the medical assistant-certified training and certification requirements to expand the types of apprenticeship programs accepted to meet the training requirements to allow experienced medical assistants to enter the Washington workforce more easily. Engrossed Substitute House Bill (ESHB) 1073 (Chapter 134, Laws of 2023). WAC 246-827-0010, 246-827-0200, and 246-827-0240, new section WAC 246-827-0340.

WAC 246-918-076 (Physician Assistants) and WAC 246-919-397 (Physicians), How to obtain a temporary practice permit—Military spouse. The Washington Medical Commission will consider amending these WACs in response to Second Substitute House Bill (2SHB) 1009 (chapter 165, Laws of 2023), Military spouse employment act.

The Board of Osteopathic Medicine and Surgery is considering amending WAC 246-853-661 Exclusions, WAC 246-853-730 Periodic review, and WAC 246-853-755 Tapering requirements, to modernize the language, add clarity, and align rules with the Washington Medical Commission (WMC).

The Department of Health is considering amendments to WAC 246-835-010 and WAC 246-835-025 to clarify the definition of “culturally congruent care” and to ensure education and training requirements related to “culturally congruent care” are clear.

The Occupational Therapy Practice Board and the Department of Health are considering amending rules and establishing fees for temporary practice permits in response to the Washington Military Spouse Employment Act.

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, check the Medical Cannabis Program box. You may also check any other box of the professions listed that you may be interested in.

Shannon Angell

PO Box 47860

Olympia, WA 98504-7860

Phone: 360-236-2820

Email: shannon.angell@doh.wa.gov

The Department of Health is considering amending radioactive material licenses and licensee's fees to cover operating costs for the following: Small business discount provision and optional fee payment schedule applicable to radioactive materials licensees; Fees for specialized radioactive material licenses; Fees for medical and veterinary radioactive material use Fees for industrial radioactive material licenses; Fees for laboratory radioactive material licenses; and Fees for licensing and compliance actions.

The Pharmacy Quality Assurance Commission is considering amending WAC 246-945-055 to remove fenfluramine from the list of Schedule IV substances and adding a new section to chapter 246-945 WAC to establish a list of schedule IV exemptions. Fenfluramine is a medication used in the treatment of seizures associated with certain syndromes and as an appetite suppressant and was removed from the Drug Enforcement Administration’s (DEA) federal Controlled Substances Act (CSA) in December of 2022.

The Board of Osteopathic Medicine and Surgery is considering amending WAC 246-853-080 to update the continuing education (CE) requirements for licensure renewal of osteopathic physicians to clarify Washington-specific mandated CE requirements.

The Department of Health is considering amendments to the birth doula certification requirements in WAC 246-835-040, Applicants currently certified in other states or territories, to comply with Second Substitute House Bill (2SHB) 1724 (chapter 425, Laws of 2023).

Shad Bell

360-236-4711

The Department of Health is considering amending, repealing, or creating new sections in chapter 246-809 WAC, to establish: a directory to help mental health counselor, marriage and family therapist, and social worker associates find supervisors; minimum standards for supervision of associates; and a stipend program to offset some costs of supervision for associates.

The Department of Health is considering amending requirements for respiratory care practitioner application, examination licensure, and out of state credentialing and temporary practice permits.

The Department of Health is considering amending fees in WAC 246-358-990 to cover operating costs in the Temporary Worker Housing program. The department will consider updating or restructuring existing fees and creating new fees. Rulemaking is being considered because the department conducted an initial assessment of the program and determined the current fee is not generating sufficient revenue to cover the program’s costs.

The Emergency rule amending specific training requirements for Nursing Assistant Certified (NAC) and Nursing Assistant Registered (NAR) has been rescinded with an effective date of November 4, 2023, because it has been replaced by permanent rules in chapter 246-841A WAC.

Withdrawal of WSR 23-12-089, for chapter 246-562 WAC Physician Visa Waivers. The department is expanding the scope of the rule making project under a new CR-101.

The board is rescinding this emergency rule which amended specific training requirements for Nursing Assistant Certified (NAC) and Nursing Assistant Registered (NAR) effective November 4, 2023, because it is no longer necessary.

This memo serves as notice that the Department of Health is withdrawing CR-101, filed January 8, 2021, published under WSR 21-03-011, and CR-102 filed on May 24, 2023, published under WSR 23-11-166. The department is withdrawing this CR-101 and CR-102 because the comments received from interested parties during the public comment process indicated substantial opposition to the rule as proposed.

As a result, the department will continue to use its existing authority and rules to determine the need for new trauma centers and the optimal distribution of trauma services to ensure equitable access to trauma care. Individuals requiring information on this rule should contact Anthony Partridge, Program Manager, at anthony.partridge@doh.wa.gov.

Rescission of interpretive statement NCIS2.00 for WAC 246-840-4659 because a permanent rule has been adopted in its place. The rule clarifies the application of the advanced practice pain management rules in nursing homes and long-term acute care hospitals and incorporated the interpretive statement into permanent rule. Filed on January 31, 2024.

The board engaged in rulemaking to clarify the application of the advanced practice pain management rules in nursing homes and long-term acute care hospitals and incorporated the interpretive statement into permanent rule. The proposed rule was adopted by the board in a rule hearing on May 12, 2023. The permanent rule was filed on June 29, 2023 as WSR 23-14-082.

Rescission of Interpretive Statement BON 21-01, Continuing Education Pharmacology Documentation. Filed February 8, 2024.

The board is rescinding this interpretive statement because the board has adopted amendments to WAC 246-836-080 Continuing competency program, that clarify what forms of documentation are acceptable to verify meeting the pharmacology continuing education requirements. Thus, the interpretive statement is no longer necessary.

Individuals requiring information on this rule should contact Rachel Phipps, program manager, phone 564-233-1277, email naturopathy@doh.wa.gov.

This policy statement provided guidance to donor milk banks and insurance carriers consistent with RCW 43.70.645 until the department adopted permanent rules. The policy statement served as the milk bank safety standards established by the department for inpatient use for the purpose of RCW 43.70.645 and 48.43.815, clarified and added a definition addressing donor human milk obtained from a milk bank for the purposes of ensuring inclusion of donor milk provided by renumerated donors and ensuring inclusive language use.

The department is rescinding this policy statement because it is superseded by permanent rules that were adopted August 22, 2023, filed as WSR 23-17-149 with an effective date of September 22, 2023, making the policy statement obsolete.

Individuals requiring information on this should contact Me'kyel Bailey, lead policy advisor, email mekyel.bailey@doh.wa.gov, or phone 360-754-9161. Filed February 5, 2024.

The Department of Health is rescinded the CR-103E for the Sixth Emergency rule for proprietary treatment products and the use of substitution products under WAC 246-272A-0110, published as WSR 24-04-071 because a permanent rule WSR 24-06-046 filed on March 1, 2024 makes the emergency rule redundant.

Rescission of Policy Statement P004, Regulatory Standards Applicable to Remote Dispensing Sites. Filed February 8, 2024.

The pharmacy quality assurance commission (commission) is rescinding the policy statement Regulatory Standards Applicable to Remote Dispensing Sites, which was filed on July 2, 2020, and published as WSR 20-15-011.

The department of health is rescinding this policy statement because rulemaking was completed allowing a pharmacy to extend its pharmacy license to a remote dispensing site where technology is used to dispense medications used for the treatment of opioid use disorder or its symptoms. The CR-103P was filed under WSR 24-01-098 and went into effect on January 18, 2024.

Individuals requiring information on this rule should contact Joshua Munroe, rules and legislative consultant, phone 360-502-5058, email PharmacyRules@doh.wa.gov. 

The Department of Health withdrew the CR-101 published as WSR 23-04-061 and the CR-102 published as WSR 23-23-186 for WAC 246-282-990, Shellfish fees, because the 2024 Legislature passed a budget proviso that gives the department funding to contract with an independent third-party consultant to study the commercial shellfish regulatory program and make recommendations on fees. The budget proviso prohibits the department from increasing commercial shellfish fees during fiscal year 2025. Filed as WSR 24-08-079 and WSR 24-08-079A.

The Department of Health rescinded the CR103E filed as WSR 24-07-062 amending behavioral health agency licensing and certification requirements because it was incomplete. The emergency rule was refiled correctly under WSR 24-07-100. Filed March 20, 2024.