Provides guidance on how to notify SAMHSA about changes in your program and what changes require notification.
Notification of Program Changes
Per federal regulations opioid treatment programs (OTPs) must notify SAMHSA of changes to their existing program by logging into the SAMHSA OTP Extranet and submitting the online Form SMA-162: Application for Certification to Use Opioid Drugs in a Treatment Program.
A separate Form 162 is required for each change. OTPs may not submit multiple changes on one form. On Form SMA-162, OTPs must select the type of change for which they are reporting.
Existing OTP program sponsors should have an individual SAMHSA OTP Extranet account. For instructions on accessing your program’s account, contact the SAMHSA OTP Extranet Helpdesk at:
To establish a SAMHSA OTP Extranet user account, send a request.
Only an OTP program sponsor may sign and submit a Form SMA-162. The program sponsor’s name and contact information, including telephone number and email address are required. An acknowledgement email will be sent to the sponsor after the form is submitted online. The sponsor will need to electronically sign the form to complete the submission process via a link supplied in the confirmation email. Once reviewed and approved, SAMHSA will send an email containing the approval letter.
If further information is required, SAMHSA will contact the program sponsor.
Learn more about OTP accreditation and certification for opening a treatment program.
What Program Changes Require SAMHSA Notification?
Within three weeks, existing OTPs must notify SAMHSA of any replacement or other change in the status of the following using the online Form SMA-162 located on the SAMHSA OTP Extranet:
- Change of program sponsor
- Change of medical director
In addition, existing OTPs must submit via the SAMHSA OTP Extranet and receive SAMHSA approval for:
- Relocation of primary dispensing unit or a medication unit
- Addition of a new medication unit(s) (brick and mortar or mobile units)
OTPs are required to notify SAMHSA’s Division of Pharmacologic Therapies (DPT) at DPT@samhsa.hhs.gov or directly to the SAMHSA Compliance Officer for their state for the following changes:
- Change of ownership
- Program name changes
- Voluntary or Involuntary Program Closures
Program Change Required Documentation
Each change notification purpose requires different supporting documentation. Upload documentation and submit with each Form SMA-162. Additional documentation is not required, if the change is not listed below.
Acceptable formats for uploading files are the following:
- Text files
- TIFF image files
- PDF files
- Word documents (.doc or .docx)
For a new medical director, please provide:
- A copy of the medical director’s DEA registration
- A copy of the medical director’s state license
- A copy of the medical director’s curriculum vitae
- A written statement acknowledging that the medical director will work only at this facility or, if the medical director is also the medical director for another treatment program, enclose a written justification for the feasibility of such an arrangement. This justification should address the portion of the medical director’s time spent in treating unrelated medical patients and participating on boards and committees.
For relocating a primary dispensing unit or medication unit, please provide:
- A detailed labeled floor diagram for all areas of the building.
- A written description of the facilities to be used by this 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.
For adding a new medication unit, please provide:
- A justification for the need to establish a medication unit
- A description of how the medication unit receives the medication supply must be explained in the application.
- An affirmative statement that the medication unit is limited to administering and dispensing the narcotic treatment drug and collecting samples for drug testing or analysis.
- An affirmative statement that the sponsor agrees to retain responsibility for patient care.
- A detailed labeled floor diagram of the medication unit.
- A written description of the facilities to be used as a medication unit.
- The total number of patients to be served by the primary facility and medication unit.
- The name and address of any medication unit or units currently attached to the primary facility.
- The total number of patients that will be served only at the medication unit.