Programs seeking provisional certification as an OTP must use the online Form SMA-162: Application for Certification to Use Opioid Drugs in a Treatment Program. The OTP completes and electronically submits the SMA-162 to SAMHSA. The Provisional Certification box on the SMA-162 form should be checked. Applicants are urged to adhere closely to the instructions provided on the SAMHSA Web site.
SAMHSA will carefully review the form and application packet for completeness and notify the OTP of the need for additional information or clarification. Incomplete applications will require a longer time to process.
Simultaneously, OTPs should complete applications for the respective DEA and State Inspections. The SAMHSA Compliance Officer will seek approvals from each entity, utilizing an internal approval form, which must be returned to the Compliance Officer. Once all documents, including approvals from the respective State and DEA are satisfied, the Compliance Officer will seek leadership approval for the provisional certification of the OTP. SAMHSA requests 45 days from the receipt of the provisional application to render a decision.
Programs may view the submission requirements.
The provisional OTP certification is a triplicate process. SAMHSA approval is contingent upon state and DEA approvals. Please consult your local DEA and state opioid treatment authority (SOTA) for additional guidance.
No. An OTP seeking a provisional certification must provide evidence of a separate application for accreditation as an OTP, through one of the six approved SAMHSA accrediting bodies. View a list of SAMHSA-approved accrediting bodies.
An “in processing” status indicates the SMA-162 has not been marked ‘complete,’ thus the program’s renewal certification remains outstanding. In order to complete this process, the OTP must submit a copy of the full accreditation survey report. You may submit this documentation to DPT@samhsa.hhs.gov. Please do not submit a duplicate SMA-162 for renewal certification if you notice that the current SMA-162 for the OTP is “in processing” as this will complicate the OTP’s renewal application process.
Prior to the certification expiration date, please send an email to the assigned Compliance Officer indicating the reason for the extension request. If the extension request is due to an upcoming accreditation survey timeframe, please provide documentation from the accreditation body. You must still submit a SMA-162 form via the OTP Extranet for certification renewal as this will be necessary to complete processing the renewal request. Compliance Officers are available for questions, concerns, and help with navigating the extension request process. Feel free to email us at DPT@samhsa.hhs.gov.
For OTPs that are relocating and/or whose address changes are substantially different from that which was entered on the SMA-162 for the provisional application, a new SMA-162 for a relocation must be submitted. Required documentation includes:
- A detailed labeled floor diagram for all areas of the building. Please be sure to include the location of dispensing windows, the Medical Director’s office, nurses’ stations/offices, counselors’ offices, and where individual and group counseling will take place.
- A written description of the facilities to be used by the program. Demonstrate how the facilities are adequate for drug dispensing and for individual and group counseling. The description shall specify how the OTP will provide adequate medical, counseling, vocational, educational, and assessment services at the primary facility, unless the program sponsor has entered into a formal documented agreement with another entity.
In the event the Program Sponsor enters the OTP’s address incorrectly on the provisional application and later identifies this error AND the error is not significantly different from the original entry (i.e., same street number and address, but excluded the suite number, etc.), then the Program Sponsor should notify the appropriate Compliance Officer and submit the OTP’s state license and DEA registration with matching addresses. This change is manually completed by the Compliance Officer and is typically updated in the extranet within 48 hours.
Program Sponsors should NOT attempt to change the address of the OTP via a certification renewal application. A separate relocation SMA-162 should be submitted if the address change meets the relocation criteria.
If a program is requesting the practitioner be granted the ability to approve take-home medication § 8.12 (i) Unsupervised or "take‐home" use, the following documents must be uploaded with the application:
- Mid-Level’s CV
- Mid Level’s current DEA License
- Mid-Level’s current State License
- Mid-Level’s Evidence of MOUD Training
All documents must be uploaded for each MLE request. Please do not upload documents that are not listed above. Mid-level exemption requests will be rejected if incomplete requests are received and/or if documents (i.e., medical licenses, DEA registrations, etc. are expired). This is applicable in states that support this scope of mid-level practitioners in OTPs. SOTA approval via the OTP extranet is required for all MLE requests except ones submitted by Federal OTPs.
If a program is not requesting the mid-level practitioner be granted take-home medication approval provisions, the only documentation required is the practitioner’s evidence of MAT training.