Opioid Treatment Program (OTP) Mobile Units

The Department of Health (DOH) revised WAC 246-341-0342 (PDF) to allow opioid treatment programs (OTPs) to add a mobile unit as an extension of an existing OTP license. OTPs that plan to operate a mobile unit must also comply with Title 21 of the Code of Federal Regulations (C.F.R.) Parts 1300, 1301, and 1304.

*Note: The mobile unit may only provide services for which the OTP is currently certified to provide. If the mobile unit will be providing additional services those must be added to the BHA license before the mobile unit will be approved.

OTP Mobile Unit Approval Process

Before operating a mobile unit, an OTP must complete the steps in the order they appear below.  Once the Drug Other Controlled Substance Registration application and OTP Mobile Unit Notification application are approved, DOH will notify the agency and the State Opioid Treatment Authority (SOTA). 

Department of Health
P.O. Box 1099
Olympia, WA  98507-1099

  • Obtain approval from the State Opioid Treatment Authority (SOTA).
  • Obtain approval from the Substance Abuse and Mental Health Services Administration.
SOTA and SAMHSA Approval
  • The Substance Abuse and Mental Health Services Administration (SAMHSA) requires the OTP sponsor to submit an online SMA-162 form.
  • OTPs must secure approval from the State Opioid Treatment Authority (SOTA) before SAMHSA will approve the on-line SMA-162 form. Contact the SOTA for more information.
Frequently Asked Questions

What are the requirements for adding a mobile unit to an existing Opioid Treatment Program (OTP) license? 

The Department of Health (DOH) implemented emergency rules (PDF) to allow OTPs to add a mobile unit as an extension of an existing OTP license. OTPs that plan to operate a mobile unit must also comply with Title 21 of the Code of Federal Regulations (C.F.R.) Parts 1300, 1301, and 1304.

The process and forms are located on the department’s OTP Mobile Unit webpage. Steps should be completed in the following order and include:

Department of Health
P.O. Box 1099
Olympia, WA 98507-1099

  • Obtaining approval from the State Opioid Treatment Authority (SOTA) (see below).
  • Obtaining approval from the Substance Abuse and Mental Health Services Administration (SAMHSA) (see below).

Will OTP mobile units be inspected prior to approval?

Yes. The Pharmacy Quality Assurance Commission (PQAC) will inspect the mobile unit for the Drug Other Controlled Substance Registration prior to approval. Pharmacy staff will reach out to you to schedule the inspection. The DEA will also conduct an inspection before approving the mobile unit. As a final step, the State Opioid Treatment Authority (SOTA) will do a walk-through of the mobile unit.

How does an OTP get approval from the Drug Enforcement Agency (DEA)?

OTPs should reach out to the local DEA for guidance. The DEA will conduct an inspection of the mobile unit in addition to the Pharmacy Quality Assurance Commission (PQAC) inspection.

What is the timing of the Pharmacy Quality Assurance Commission (PQAC) inspection and DEA inspection?

OTPs should submit the Drug Other Controlled Substance Registration first. The DEA will expect that to be completed before they inspect the mobile unit and provide their approval.

Depending on staff availability, there may be an option to complete both the PQAC inspection for the Drug Other Controlled Substance Registration and the DEA inspection simultaneously. Pharmacy inspection staff will connect with DEA inspection staff to see if schedules will align for this option. 

Do OTPs need approval from the State Opioid Treatment Authority (SOTA)?

Yes. SAMHSA requires SOTA approval before they will approve the online SMA-162 notification form. Once the SOTA receives notification from the department that the Drug Other Controlled Substance Registration and OTP Mobile Unit Notification application was approved, the office of the SOTA will approve the unit. The SOTA will reach out to the OTP if additional information is needed prior to approval.

How does an OTP get approval from SAMHSA?

SAMHSA requires OTPs to submit an online SMA-162 notification form for the mobile unit to the extranet site. SOTA approval will be needed before SAMHSA approves the online form.

Why is a Drug Other Controlled Substance Registration needed since the OTP Mobile Unit is considered an extension of the existing license under new federal regulations?

RCW 69.50.302 requires that every person who manufactures, distributes, or dispenses any controlled substances within Washington state to obtain an annual registration with the department in accordance with PQAC’s rules. To be in compliance with PQAC regulations, OTPs must obtain a separate Drug Other Controlled Substance Registration for each mobile unit in accordance with WAC 246-945-060.

Does the OTP Mobile Unit need to adhere to both the DEA and PQAC’s rules?

Yes. However, where the updated DEA regulations in 21 C.F.R. and WAC 246-945-060 overlap, the OTP Mobile Unit will need to adhere to the more restrictive requirement in order to be compliant with both. For example, WAC 246-945-060(4) requires controlled substances to be stored in “a substantially constructed locked cabinet” while 21 CFR § 1301.72 has more specific requirements around the safe used for drug storage installed in the OTP Mobile Unit.

Are policies and procedures required for OTP mobile units?

If you are federally accredited by DOH, then you will need to have policies and procedures that reflect regulations for any *expanded services that will be provided in the mobile unit. These are NOT required to be submitted with your Mobile Unit Notification Application; however, they will be reviewed during routine inspections. 

*Expanded services are services outlined in the SAMHSA guidance letter.

If the OTP is NOT accredited by the department, the OTP will need to contact their federal accreditation body for their requirements.

How long does it take for state approval?
Timeframes are largely dependent on how quickly the DEA and the DOH can complete their inspection of the mobile unit. To assure that inspections are scheduled as soon as possible it is important to submit applications, including the Drug Other Controlled Substance Registration application, that are completed in full. Information missing on the applications may result in delays.

How do I know when my notification and registration is approved?

DOH will notify the OTP and the State Opioid Treatment Authority (SOTA) when the Drug Other Controlled Substance Registration and Mobile Unit Notification are approved. SAMHSA approval is the responsibility of the OTP and can be coordinated through the SOTA.

What state regulations apply to OTP mobile units? 

Behavioral Health Agency Licensing and Certification - Emergency rule adopted for WAC 246-341-0342

Pharmacy Quality Assurance Commission

What federal regulations apply to OTP mobile units?

OTPs that plan to operate a mobile unit must comply with Title 21 of the Code of Federal Regulations (C.F.R.) Parts 1300, 1301, and 1304.

What address do we use on applications related to mobile units?

The address for the mobile unit is the same as the licensed brick and mortar OTP that the mobile unit will be attached to.

Who may I contact if I have questions?

Overall process questions:

Michelle Weatherly
Facilities Program Manager
Email: michelle.weatherly@doh.wa.gov 
Phone: 360-236-2992

Pharmacy Quality Assurance Commission – Drug Other Controlled Substance Registration questions:
WSPQAC@doh.wa.gov

Application status questions: 
HSQAFC@doh.wa.gov 

Drug Enforcement Agency questions:
Seattle.diversion@dea.gov 

Questions about the SOTA and SAMHSA approval process:
Jessica Blose
State Opioid Treatment Authority
Email: Jessica.blose@hca.wa.gov
Phone: 360-643-7850

Contact information

General questions about mobile units:
Michelle Weatherly
Facilities Program Manager
Michelle.weatherly@doh.wa.gov
Email: Phone: 360-236-2992

Questions about the drug other controlled substance registration:
WSPQAC@doh.wa.gov

Questions about application status:
HSQAFC@doh.wa.gov

Questions about the DEA approval process:
Seattle.diversion@dea.gov

Questions about the SOTA and SAMHSA approval process:
Jessica Blose
State Opioid Treatment Authority
Washington State Health Care Authority
Email: Jessica.blose@hca.wa.gov
Phone: 360-643-7850

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