Find instructions for notifying SAMHSA of changes to an existing opioid treatment program (OTP), including a relocation or a change in medical director or sponsor.
Programs must notify SAMHSA of changes to an existing opioid treatment program (OTP) by submitting the online Form SMA-162: Application for Certification to Use Opioid Drugs in a Treatment Program.
All OTPs should already have an account on the SAMHSA OTP Extranet website. For instructions on accessing your program’s account, contact the SAMHSA OTP Extranet Information Center at:
- 866-OTP-CSAT (866-687-2728)
What Changes to an Existing OTP Require Notification of SAMHSA?
Existing OTPs must notify SAMHSA within three weeks of either of the following program changes:
In addition, existing OTPs must receive approval from SAMHSA for:
What Supporting Documentation Is Required When Notifying SAMHSA of Program Changes?
Each notification purpose requires different supporting documentation. This documentation can be uploaded along with Form SMA-162. The acceptable file(s) for uploading may be in any of the following formats:
- 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
- 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 a new program sponsor, please provide:
- A government-issued picture ID
Step-by-Step Application Instructions for New Program Sponsors
- Access the online Form SMA-162: Application for Certification to Use Opioid Drugs in a Treatment Program.
- In the first row, under “Purpose of Application,” select “New Sponsor.”
- Answer question 1a and the application will pre-populate.
- Update the program sponsor section, which includes questions 6, 7, and 8.
- Review the full application and confirm that the auto-filled information is accurate.
- To continue, choose the “Next” button at the bottom of the page.
- Upload required supporting documentation.
- To submit the application, choose the “Submit” button at the bottom of the form.
- To help you sign the form electronically, SAMHSA will send you an email with instructions. If this step is not completed, the application cannot be accepted or processed.
For relocating a primary dispensing unit or medication unit, provide a diagram and description of the facilities to be used by this program, which demonstrates 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 description of how the medication unit receives the medication supply from the primary facility
- 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 diagram and 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 total number of patients that will be served only at the medication unit
- A justification for the need to establish a medication unit
- The name and address of any medication unit or units currently attached to the primary facility
Who May Submit Form SMA-162?
Form SMA-162 may only be submitted and signed by an OTP program sponsor. The program sponsor’s name and contact information, including telephone number and email address are required. A confirmation email will be sent to the sponsor after the form is submitted online. The sponsor will need to electronically sign the form and complete the submission process via a link supplied in the confirmation email. SAMHSA will contact the sponsor after receipt of a completed form if further information is required.
For more information about OTP certification and opening a treatment program, contact one of SAMHSA’s regional OTP Compliance Officers.
Expanding OTP Services Through Medication Units
SAMHSA is working closely with opioid treatment professionals to expand access to OTP services through the creation of medication units. A medication unit is a facility that is geographically separated from where an OTP is headquartered. Medication-assisted treatment (MAT) professionals can administer medications, collect samples, and conduct drug testing and analysis from medication units. However, admission services and addiction counseling cannot be conducted within these facilities.
Medication units allow MAT patients to establish a routine and maintain a productive life. This can be especially helpful for people living in rural areas where the nearest OTP site may be 70 miles away or more. Even in major cities, medication units may be needed to help cut down on long wait times at busy OTP sites.
Medication units must follow the same rules and guidelines as outlined by SAMHSA and the state in which they reside, and must apply and renew for certification. Access training materials and case studies that help explain the federal regulations governing medication units.
To receive SAMHSA certification for your medication unit, use the online application Form SMA-162.