Opioid Treatment Program (OTP) Mobile Units

Chapter 246-341 WAC allows 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.

Title 42 of the Code of Federal Regulations (C.F.R.) Part 8.

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

OTP Mobile Unit Approval Process

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

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) rules in chapter 246-341 WAC 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.

Title 42 of the Code of Federal Regulations (C.F.R.) Part 8.

Before operating a mobile unit, an OTP must complete the steps 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) may 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 DOH 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 each mobile unit to the extranet site. SOTA approval will be needed before SAMHSA approves the online form.

Please note that if you plan to operate more than one mobile unit, you will be required to complete an SMA-162 for each unit.

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?

Policies and procedures from your main site OTP will apply to the mobile unit. However, OTPs may need to update policies and procedures to include an emergency plan specific to the mobile unit. In addition, other policies and procedures may need to be updated or added if there is a specific difference with the mobile unit. OTPs can add a section to the existing policies and procedures regarding any differences.

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

Is a community relations plan needed for an OTP mobile 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 mobile 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 state regulations apply to OTP mobile units? 

Behavioral Health Agency Licensing and Certification

Pharmacy Quality Assurance Commission

What federal regulations apply to OTP mobile units?

OTPs that plan to operate a mobile unit must comply with:

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. The State Opioid Treatment Authority may require you to provide an address where the mobile unit will park daily.

Resources
Contact information

Questions about OTP mobile unit approval or licensing and certification requirements in chapter 246-341 WAC:

Michelle Weatherly
Facilities program manager
Michelle.weatherly@doh.wa.gov
Phone: 360-236-2992

Questions for the SOTA:

Jessica Blose
State Opioid Treatment Authority
Washington State Health Care Authority
Email: Jessica.blose@hca.wa.gov
Phone: 360-643-7850

Questions about the Pharmacy Quality Assurance Commission Drug Other Controlled Substance registration, email WSPQAC@doh.wa.gov (WSPQAC@doh.wa.gov)

Questions about application status, email HSQAFC@doh.wa.gov (HSQAFC@doh.wa.gov)

Questions about the DEA approval process, email Seattle.diversion@dea.gov (seattle.diversion@dea.gov)