The Department of Health (DOH) revised chapter 246-341 WAC to allow opioid treatment programs (OTPs) to establish a fixed-site medication unit as part of, but geographically separate from, an existing licensed OTP. OTPs that plan to operate a fixed-site medication unit must also comply with:
Title 21 of the Code of Federal Regulations (C.F.R.) Parts 1300, 1301, and 1304.
Title 42 of the Code of Federal Regulations (C.F.R.) Part 8.
*Notes: The fixed-site medication unit may only provide services for which the OTP is currently certified to provide. If the medication unit plans to provide additional services those must be added to the BHA license before the unit is approved.
- OTP Fixed-site Medication Unit Approval Process
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Before operating a fixed-site medication unit, an OTP must complete the steps below:
Submit a Medication Unit Notification Form to DOH (PDF)
Obtain a Drug Other Controlled Substance Registration (DRCS) (PDF) from the Pharmacy Quality Assurance Commission (PQAC)
Submit Form SMA-162 to SAMHSA. This can be done using SAMHSA’s OTP Extranet.
SAMHSA will forward the SMA-162 approval to the DEA.
Obtain a federal Drug Enforcement Administration registration.
The DEA will arrange an inspection.
DOH will notify the State Opioid Treatment Authority (SOTA) when OTP has an active DRCS and approved notification form.
Other considerations:
OTPs should determine if there is a need for a Medical Test Site license from the DOH. If you need assistance determining whether your facility or fixed-site medication unit needs a medical test site license, contact us via email or call 360-236-4661.
- Frequently Asked Questions
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What is a fixed-site medication unit?
A fixed-site brick and mortar entity is established as part of, but geographically separate from, an opioid treatment program from which appropriately licensed opioid treatment program practitioners, contractors working on behalf of the OTP, or community pharmacists may dispense or administer medication for opioid use disorder, collect samples for drug testing or analysis, or provide other opioid treatment program services (WAC 246-341-0200).
Are fixed-site medication units new?
They are not new at the federal level. SAMHSA already had rules in place for fixed-site medication units to allow existing opioid treatment programs to open brick-and-mortar medication unit as an extension location. The Washington State Legislature passed Senate Bill 5536 (PDF) during the 2023-24 legislative session allowing these medication units to be established as part of a licensed OTP. New rules can be found in chapter 246-341 WAC. Medication units are intended to expand access to care and to help reach rural areas and underserved populations.
How is a fixed-site medication unit different than an OTP mobile unit?
Both a fixed-site and a mobile medication unit are part of an existing licensed OTP that can provide OTP services. However, a fixed-site medication unit is a brick-and-mortar entity, geographically separate from the main OTP, and requires a unique DEA registration because medications can be stored at a fixed-site location. The mobile unit is a vehicle, has the same DEA registration as its main OTP, must return to the main OTP at the end of each day, and may not store medications.
Where can a fixed-site medication unit be located?
May be located in a variety of different settings, including, but not limited to:
- Certified Behavioral Health Centers
- Community mental health centers
- Federally Qualified Health Centers and other primary care practices
- Community pharmacies
- Correctional facilities
- Stand-alone facility
Who is responsible for the operation of the medication unit?
The OTP Program Sponsor at the main OTP site is responsible for the operation of the medication unit and assumes the responsibility for all its employees, including any practitioners, agents, or other persons providing medical, behavioral health, or social services (42 CFR Part 8.2).
Is there a limit on the distance the medication unit can be from the main OTP site?
Although there is no set limit on the distance a medication unit can be from the main OTP, the Program Sponsor of the main OTP is responsible for all their associated medication units. OTPs should keep this in mind when choosing a location.
Is a community relations plan needed for a fixed-site medication unit?
All main site OTPs must have a community relations plan completed for licensure that includes a requirement to develop an ongoing community relations plan to address new information. OTPs should use the ongoing plan to document community outreach where the fixed-site medication unit plans to be located, to include documenting input, concerns, and how those concerns will be mitigated. Community relations plans are subject to review during routine surveys or complaint investigations.
What should we know about siting a fixed-site medication unit?
In addition to community relations mentioned above, OTPs should consult with the appropriate city and county offices to ensure the medication unit is properly sited. This documentation can be included in the ongoing community relations plan.
Do OTPs need separate accreditation for their fixed-site medication unit?
Since medication units are part of the primary OTP, existing accreditation standards will apply to the medication unit. There is currently no additional fee.
DO OTPs need to have separate policies and procedures for their fixed-site medication unit?
Policies and procedures from your main site OTP will apply to the fixed-site medication unit. However, OTPs may need to update policies and procedures to include an emergency plan specific to the fixed-site medication unit since it is geographically separate from the main site. In addition, other policies and procedures may need to be updated or added if there is a specific difference at the fixed-site medication unit. OTPs can add a section to the existing policies and procedures regarding any differences.
- Contact Information
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Questions about fixed-site medication unit approval or licensing and certification requirements in chapter 246-341 WAC:
Michelle Weatherly
Facilities program manager
Michelle.weatherly@doh.wa.gov
360-236-2992Questions for the SOTA:
Jessica Blose
State Opioid Treatment Authority
Washington State Health Care Authority
Jessica.blose@hca.wa.gov
360-643-7850Questions about the Pharmacy Quality Assurance Commission Drug Other Controlled Substance registration, email WSPQAC@doh.wa.gov (WSPQAC@doh.wa.gov).
Questions about the status of a DOH application, email HSQAFC@doh.wa.gov (HSQAFC@doh.wa.gov).
Questions about the DEA approval process, email seattle.diversion@dea.gov (seattle.diversion@dea.gov).
- Laws and Regulations
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Washington state regulations
- Chapter 246-341 WAC – Behavioral Health Agency Licensing and Certification Requirements.
- WAC 246-341-0300 – Agency Licensure and Certification
- WAC 246-341-1000 – OTP Certification Standards
- WAC 246-945-040 – Uniform Controlled Substance Act
- WAC 246-945-060 – Other controlled substance registrants - Requirements
Washington state laws
- RCW 71.24.590 – Opioid treatment – Program licensing or certification by department, department duties – Use of medications by program – Definition.
Federal regulations and guidance
- Resources