WSR 26-09-118
PROPOSED RULES
DEPARTMENT OF HEALTH
(Pharmacy Quality Assurance Commission)
[Filed April 21, 2026, 8:51 a.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 23-18-046.
Title of Rule and Other Identifying Information: Pharmacy registration for mobile opioid treatment program units. The pharmacy quality assurance commission (commission) is proposing amendments to researcher and other controlled substance registration rules, WAC 246-945-060 and 246-945-250, to add registration exemptions for mobile opioid treatment program (OTP) units and amend facility requirements for other controlled substance registrants.
Hearing Location(s): On May 28, 2026, at 1:00 p.m., at the Department of Labor and Industries, 7273 Linderson Way S.W., Tumwater, WA 98501; or virtual via Zoom at https://us02web.zoom.us/j/86309299195 or https://zoom.us/join, Webinar ID 863 0929 9195; or One-tap mobile +12532158782,,86309299195# US (Tacoma), +12532050468,,86309299195# US; or phone: Dial (for higher quality, dial a number based on your current location) +1 253 215 8782 US (Tacoma), +1 253 205 0468 US.
Date of Intended Adoption: May 28, 2026.
Submit Written Comments to: Haleigh Mauldin, P.O. Box 47852, Olympia, WA 98504-7852, email PharmacyRules@doh.wa.gov, web https://fortress.wa.gov/doh/policyreview/, beginning at the time and date of filing, by May 14, 2026, at 11:59 p.m.
Assistance for Persons with Disabilities: Contact Haleigh Mauldin, phone 360-236-4946, TTY 711, email PharmacyRules@doh.wa.gov, by April 30, 2026.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The commission is proposing amending WAC 246-945-060 and 246-945-250 to exempt mobile OTP units from having to obtain separate registrations, as long as they are covered under the OTP site's controlled substance registration, and to incorporate comprehensive facility requirements for analytical laboratories and dog handlers among other facilities that are licensed under the other controlled substance registration.
To operate in Washington state and possess controlled substances, OTPs must be licensed by the Washington department of health (department) as a behavioral health agency and register with the commission to obtain an "other controlled substances registration." Previously, if an OTP were to operate a mobile component, they were required to obtain a separate registration and licensure for each mobile component in order to possess controlled substances. In July 2021, the federal Drug Enforcement Agency (DEA) lifted its moratorium on mobile units, eliminating a separate registration requirement for OTP mobile units by adding a "mobile component" to an OTP's existing registration. The department adopted permanent rules for licensed behavioral health agencies to approve these units as an extension of an existing OTP license and certification, though they must also register with the commission to possess controlled substances by obtaining the "other controlled substance registration."
While state law currently requires each mobile unit to register separately with the commission, RCW
69.50.302(4) allows the commission to waive by rule the requirement for registration of certain entities upon finding it consistent with public health and safety. The proposed rule amends WAC 246-945-060 Other controlled substance registrants—Requirements, and 246-945-250 Researcher and other controlled substance registration, to exempt mobile units from having to register separately with the commission, allowing an OTP to extend its registration to cover its mobile units. The commission determined that there is no public health and safety issue from allowing existing OTPs to cover mobile units because the mobile unit would still be operating under the authority, oversight, and other controlled substance registration of the existing OTP license and all drugs return to the existing OTP each night. This change is intended to reduce administrative burden for OTPs that wish to expand services by adding mobile components to their registrations. These mobile units increase access to treatment for Washingtonians with opioid use disorder to assist in combating the ongoing opioid epidemic, which the commission considers a significant public health issue.
The amended rules also incorporate comprehensive facility requirements for all other controlled substance registrants, including analytical laboratories and dog handlers, focusing on enhancing drug security and product integrity. This amendment is to align with state and federal regulations and provide clarity to licensees and inspectors regarding the commission's expectations for the controlled substance registration.
Reasons Supporting Proposal: To better align with the statute's intent, to protect public health, safety, and welfare, the commission is proposing amendments to waive the requirement that each mobile unit must register separately with the commission and incorporate comprehensive facility requirements for other controlled substance registrants. The proposed rules mirror DEA regulations and processes by incorporating sections of Title 21 C.F.R. and allowing an OTP to extend its other controlled substance registration to cover its mobile units, aligning the process with federal regulations to reduce administrative burden for registrants. The commission determined that there is no public health and safety issue from allowing existing OTPs to cover mobile units because the mobile unit would still be operating under the authority, oversight, and other controlled substance registration of the existing OTP license and all drugs return to the existing OTP each night.
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: Haleigh Mauldin, 111 Israel Road S.E., Tumwater, WA 98501, 360-890-0720; Enforcement: Marlee O'Neill, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4946.
A school district fiscal impact statement is not required under RCW
28A.305.135.
A cost-benefit analysis is required under RCW
34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Haleigh Mauldin, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4947, TTY 711, email
PharmacyRules@doh.wa.gov.
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 amendments to WAC 246-945-060 were already required in chapter
69.41 RCW and Title 21 C.F.R. Because the proposed amendments are incorporating what is already required in other state and federal regulations, they meet the requirements provided in RCW
34.05.310 (4)(c) and are eligible for exemption for the small business economic impact statement (SBEIS).
Scope of exemption for rule proposal:
Is partially exempt:
Explanation of partial exemptions: [See below.]
The proposed rule does impose more-than-minor costs on businesses.
SBEIS
A brief description of the proposed rule, including the current situation/rule, followed by the history of the issue and why the proposed rule is needed. A description of the probable compliance requirements and the kinds of professional services that a small business is likely to need in order to comply with the proposed rule: The commission is proposing amending WAC 246-945-060 and 246-945-250 to exempt mobile OTP units from having to obtain separate registrations, as long as they are covered under the OTP site's controlled substance registration, and to incorporate comprehensive facility requirements for analytical laboratories and dog handlers among other facilities that are licensed under the other controlled substance registration.
To operate in Washington state and possess controlled substances, OTPs must be licensed by the department as a behavioral health agency and register with the commission to obtain an "other controlled substances registration." Previously, if an OTP were to operate a mobile component, they were required to obtain a separate registration and licensure for each mobile component in order to possess controlled substances. In July 2021, DEA lifted its moratorium on mobile units, eliminating a separate registration requirement for OTP mobile units by adding a "mobile component" to an OTP's existing registration. The department adopted permanent rules for licensed behavioral health agencies to approve these units as an extension of an existing OTP license and certification, though they must also register with the commission to possess controlled substances by obtaining the "other controlled substance registration."
While state law currently requires each mobile unit to register separately with the commission, RCW
69.50.302(4) allows the commission to waive by rule the requirement for registration of certain entities upon finding it consistent with public health and safety. The proposed rule amends WAC 246-945-060 Other controlled substance registrants—Requirements, and 246-945-250 Researcher and other controlled substance registration, to exempt mobile units from having to register separately with the commission, allowing an OTP to extend its registration to cover its mobile units. The commission determined that there is no public health and safety issue from allowing existing OTPs to cover mobile units because the mobile unit would still be operating under the authority, oversight, and other controlled substance registration of the existing OTP license and all drugs return to the existing OTP each night. This change is intended to reduce administrative burden for OTPs that wish to expand services by adding mobile components to their registrations. These mobile units increase access to treatment for Washingtonians with opioid use disorder to assist in combating the ongoing opioid epidemic, which the commission considers a significant public health issue.
The amended rules also incorporate comprehensive facility requirements for all other controlled substance registrants, including analytical laboratories and dog handlers, focusing on enhancing drug security and product integrity. This amendment is to align with federal and state regulations and provide clarity to licensees and inspectors regarding the commission's expectations for the controlled substance registration.
In order to comply with the proposed rule, OTPs that would like to add a mobile unit must notify the commission within 30 days and pay an inspection fee of $400. After the initial inspection fee, the mobile unit would be included with the OTP's existing registration and would not incur additional licensing costs.
Identification and summary of which businesses are required to comply with the proposed rule using the North American Industry Classification System (NAICS):
Table 1. Summary of Businesses Required to
Comply to the Proposed Rule
| NAICS Code (4, 5, or 6 Digit) | NAICS Business Description | Number of Businesses in Washington State | Minor Cost Threshold | |
| 621420 | Outpatient Mental Health and Substance Abuse Centers | 239 | $8,531.28 | |
| 541380 | Testing Laboratories and Services | 203 | $7,988 | |
| 541715 | Research and Development | 322 | $38,114 | |
| 611310 | Schools (Laboratories) | 149 | $11,015 | |
Analysis of probable costs of businesses in the industry to comply to the proposed rule and includes the cost of equipment, supplies, labor, professional services, and administrative costs. The analysis considers if compliance with the proposed rule will cause businesses in the industry to lose sales or revenue:
Exempted from Analysis: WAC 246-945-060 Other controlled substance registrants—Requirements.
Description: The current rule establishes the requirements for licensees holding other controlled substance registrations including inventory and drug storage rules, among others. The proposed amendments to WAC 246-945-060 develop more comprehensive facility requirements for other controlled substance registrants and provide definitions for "mobile unit" and "opioid treatment program." The facility requirements listed in the proposed amendments are incorporations of requirements found in other state and federal regulations. The additions to WAC 246-945-060 were already required in chapter
69.41 RCW and Title 21 C.F.R. Because the proposed amendments are incorporating what is already required in other state and federal regulations, they meet the requirements provided in RCW
34.05.310 (4)(d) and are eligible for exemption from analysis.
WAC 246-945-250 Researcher and other controlled substance registration.
Description: The current rule establishes the application process for initial registration and renewal for researchers or those designated as other controlled substance registrants. Currently, each mobile unit must apply for an initial other controlled substance registration which incurs a fee of $360. On top of the initial fee, each mobile unit must renew their registration annually for another $360.
The proposed amendments to WAC 246-945-250 outline the application process, notification requirements, when inspections are required, and related fees for the addition, for researcher and other controlled substance registrations. The amendments note that adding a mobile unit would not require a separate registration with an annual renewal fee; however, it would incur an inspection fee of $400 since adding a mobile unit would be considered a modification.
Cost(s): The proposed amendments to WAC 246-945-250 have the greatest effect on OTPs wanting to add a mobile unit. There are approximately 14 mobile units currently operating in Washington state that are run by five OTP facilities. For simplicity, the department and commission produced a costing example for one OTP facility operating one mobile [unit] over multiple years without changes. The department and commission acknowledge that many OTP facilities run multiple mobile units and anticipate that all OTP facilities will incur cost savings over time under the proposed rule.
Each mobile unit currently holds a separate other controlled substances registration, but with the proposed amendments, the OTPs would be required to notify the commission and pay an inspection fee ($400) when adding a mobile unit. They must also notify the commission when removing a unit and receive an inspection, but there is no associated fee. This would mean that an OTP would only have to pay the one-time $400 inspection fee when they add a mobile unit instead of an initial (one-time) other controlled substance registration fee ($360) and yearly renewals ($360). Although the initial cost of the proposed rule is $40 more, OTPs will incur cost savings within two years because they will no longer be required to pay annual renewal fees for each mobile unit. As the rule is currently written, an OTP would pay $720 in initial application fees and annual renewal fees in two years for a separate registration, but with the proposed rule, the OTP would only have to pay the one-time $400 for the initial inspection for each mobile unit to extend its registration results in a cost savings of $360 in the following year, or year two, plus savings of $360 each additional year. Costs and potential savings between current and proposed rule for a single OTP facility operating a single mobile unit is depicted in Table 1 [2].
Table 1 [2]. Understanding Costs Between Current and Proposed Rules for OTP Facilities Operating a Single Mobile Unit*
Rule | Initial Cost | Annual Fee | First Year Costs | Second Year Costs | Savings in Year Two | Savings Each Additional Year |
Current | $360 Licensing fee | $360 | $360 | $360 | NA | NA |
Proposed | $400 Inspection fee | $0 | $400 | $0 | ($360) | ($360) |
* | This table depicts potential costs for one OTP facility operating a single mobile unit and assumes the OTP facility does not make any changes or add any new mobile units, which could result in additional costs or savings. |
For other facility types covered by researcher and other controlled substances registrations, the amendments to WAC 246-945-250 will incur a cost. Currently, when a registrant makes modifications to their facility that negatively impacts security, an inspection, and subsequent inspection fee, is not required. The proposed amendments would require an inspection and inspection fee for these modifications. However, based on feedback from the commission's inspector supervisor, registrants rarely undergo these types of changes to structure, square footage, or security. The commission anticipates this type of inspection to occur about once every two years across all registrants (approximately 100 active researcher registrants and 100 active other controlled substance registrants) because they are infrequent. This would be a cost of $400 for the inspection fee approximately every two years for one registrant.
Analysis on if the proposed rule may impose more-than-minor costs for businesses in the industry. Includes a summary of how the costs were calculated: No, the costs of the proposed rule, an increase in costs of $40 in the first year (and potential costs in subsequent years) are less than the minor cost threshold of $8,531.28 for Outpatient Mental Health and Substance Abuse Centers; $7,988 for Testing Laboratories and Services; $38,114 for Research and Development Laboratories; and $11,015 for School Laboratories.
Summary of how the costs were calculated: The cost of compliance with this rule for OTPs was calculated by producing a costing example for one OTP facility operating one mobile [unit] over multiple years without changes. An OTP would have to pay a one-time inspection fee, $400, when they add a mobile unit. This $400 inspection fee is $40 more than the current cost of an other controlled substance registration; however, the inspection fee is a one-time cost and does not require an annual fee. By year two, OTP will incur cost savings because they are no longer required to pay annual renewal fees. Costs and potential savings between current and proposed rule for a single OTP facility operating a single mobile unit is depicted in Table 1 [2].
For other facility types covered by researcher and other controlled substance registrations, the cost of compliance for this rule was calculated by determining the frequency of modifications that negatively impact security. The amount of modifications are infrequent, one inspection approximately every two years for one registrant, so the cost was determined to be $400 for the inspection fee approximately every two years for one registrant.
The public may obtain a copy of the small business economic impact statement or the detailed cost calculations by contacting Haleigh Mauldin, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4947, TTY 711, email PharmacyRules@doh.wa.gov.
April 21, 2026
Hawkins DeFrance, PharmD, Chair
Pharmacy Quality Assurance Commission
RDS-6998.2
AMENDATORY SECTION(Amending WSR 20-12-072, filed 6/1/20, effective 7/1/20)
WAC 246-945-060Other controlled substance registrants—Requirements.
(1) All persons and firms, except persons exempt from registration, must register with the commission in order to legally possess or use controlled substances.
(2) Persons or firms which are not classified as pharmacies, wholesalers, manufacturers, or researchers will be classified as other controlled substance registrants. Examples of persons or firms in this classification include analytical laboratories, dog handlers/trainers who use dogs for drug detection purposes, school laboratories, opioid treatment programs (OTP), and other agencies which have a legitimate need to use precursor chemicals as defined in WAC 246-945-053.
(3) For the purposes of this section:
(a) "Mobile unit" means a component of an opioid treatment program that the DEA has approved to operate as a mobile narcotic treatment program pursuant to 21 C.F.R. § 1301.13.
(b) "Opioid treatment program(s)" or "OTP(s)" means a behavioral health agency that has been licensed by the department and certified as an opioid treatment program.
(4) The applicant for a controlled substance registration must complete and return an application form supplied by the commission. A list of the controlled substances to be used, the purpose for such use, and the names of the persons authorized to access the controlled substances must be listed on the application or on an addendum. An applicant for a controlled substance registration who is an OTP must also identify any mobile units operated by the agency, if any, in the application or in an addendum.
(((4) All controlled substances must be stored in a substantially constructed locked cabinet. The registrant shall maintain records in sufficient detail in order to account for the receipt, use, and disposition of all controlled substances. The registrant shall inventory all controlled substances in the possession of the registrant every two years on the anniversary of the issuances of the registration and shall maintain the inventory list for two years. The registrant shall return unwanted, outdated, or unusable controlled substances to the source from which it was obtained or surrendered to the DEA.))(5) An other controlled substance registrant shall:
(a) Ensure all controlled substances are stored in a substantially constructed locked cabinet to prevent unauthorized access;
(b) Maintain records in sufficient detail in order to account for the receipt, use, and disposition of all controlled substances;
(c) Inventory all controlled substances in the possession of the registrant every two years on the anniversary of the issuance of the registration and shall maintain the inventory for two years;
(d) Return unwanted, outdated, or unusable controlled substances to the source from which it was obtained, surrendered to the DEA, or as otherwise permitted by state and federal law; and
(e) Affix a label to every box, bottle, jar, tube, or other container that is dispensed and delivered to an ultimate user that meets the labeling requirements in RCW 69.41.050. (6) Other controlled substance registrants that are OTPs, who have notified the department that they will be operating a mobile unit must:
(a) Notify the local DEA office and receive explicit written approval from the local DEA office prior to operating the mobile opioid treatment program unit;
(b) Possess valid county/city and Washington state vehicle licensing and registration prior to transporting controlled substances;
(c) Not reverse distribute, share, or transfer controlled substances from one mobile component to another mobile component while deployed away from the registered location;
(d) Establish policies and procedures to ensure, if the mobile unit becomes inoperable, that all controlled substances on the inoperable mobile unit are accounted for, removed, and secured at the registered location of the OTP;
(e) Return to the registered location at the completion of each operation and remove all controlled substances to secure within the registered location; and
(f) Notify the commission of any changes to the information provided on the application, including the addition or removal of a mobile unit.
AMENDATORY SECTION(Amending WSR 20-12-072, filed 6/1/20, effective 7/1/20)
WAC 246-945-250Researcher and other controlled substance registration.
(1) Applicants for initial registration and renewal for researcher or other controlled substance registrations shall submit to the commission a complete application, as described in WAC 246-945-060(4), with fees relevant to the registration type.
(a) Researcher:
(i) Noncontrolled legend drugs; or
(ii) Researchers requiring to purchase, possess, administer or dispense controlled substances shall apply for a controlled substance authority on its license with the commission and register with the DEA.
(b) Other controlled substance registrations:
(i) Opioid treatment programs;
(ii) Analytical laboratories;
(iii) Dog handler; and
(iv) Other agencies who have demonstrated a legitimate need to use precursor chemicals.
(2) ((The application shall:
(a) List all legend drugs and controlled substances to be used and the purpose for its use;
(b) Name the primary registrant; and
(c) List the names of the individuals authorized to access the controlled substances.
(3) Applicants))An OTP who has notified the department they will be operating a mobile unit pursuant to chapter 246-341 WAC is not required to obtain a separate controlled substance registration for each mobile unit if the OTP's main fixed location has obtained an other controlled substance registration from the commission.
(3) Researcher and other controlled substance registrants shall notify the commission within 30 days of any changes to the information provided on their application.
(4) An applicant for initial registration and closure for researcher and other controlled substance registrations, including when an OTP removes a mobile unit from its registration, shall undergo an ((initial)) inspection ((and)). A registrant will be subject to periodic inspections as deemed appropriate by the commission.
(5) Researcher and other controlled substance registrants shall notify the commission and pay an inspection fee, as established in WAC 246-945-990 (5)(a), if any of the following occur:
(a) Changes to structural element(s) such as walls, floors, and load bearing elements that negatively impact security as determined by the registrant;
(b) Changes impacting square footage that negatively impact security as determined by the registrant;
(c) Changes to access to controlled substances that negatively impact security as determined by the registrant;
(d) Changes of location; or
(e) Adding a mobile unit to an OTP registration.
(6) For the purposes of this section:
(a) "Mobile unit" means a component of an opioid treatment program that the DEA has approved to operate as a mobile narcotic treatment program pursuant to 21 C.F.R. § 1301.13.
(b) "Opioid treatment program(s)" or "OTP(s)" means a behavioral health agency that has been licensed by the department and certified as an opioid treatment program.