Apply to have your opioid treatment program (OTP) certified by SAMHSA to dispense medications for the treatment of substance use disorders.
SAMHSA’s Division of Pharmacologic Therapies (DPT), part of the SAMHSA Center for Substance Abuse Treatment (CSAT), is responsible for certifying that an Opioid Treatment Program (OTP) conforms with federal regulations governing treatment for substance use disorders.
Before obtaining SAMHSA certification, OTPs must complete the accreditation process and meet other requirements outlined in the Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8. Learn about the federal legislation, regulations, and guidelines that apply to OTPs and medication-assisted treatment (MAT).
A program may apply for a provisional (initial) certification as it is working towards becoming accredited by a SAMHSA-approved OTP accrediting body. The provisional certification is a temporary certification granted to a new OTP for up to one year, during which time it must become accredited.
After a provisionally certified program becomes accredited, it must apply to SAMHSA for full certification via the renewal application. Once certified, OTPs must renew certification annually or every three years depending on the accreditation timeframe awarded.
Programs applying for accreditation or certification must also comply with the applicable laws and regulations in their states. Find more information about individual state regulations by contacting your State Opioid Treatment Authority.
Application for Provisional Certification to Use Opioid Drugs in Treatment
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.
Each application 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)
New applicants should prepare the following supporting documents:
- A copy of the application to the accrediting body to which your program has applied. The document should indicate the date on which your program applied for accreditation, the dates of any accreditation surveys that have taken place or are expected to take place, and the expected schedule for completing the accreditation process.
- A description of the organizational structure of the program with a chart indicating the position and title of key OTP personnel. The description should include the name and complete address of any central administration or larger organizational structure to which the OTP is responsible.
- A diagram and description of the facilities to be used by this program demonstrating 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.
- The name, address, and description of each hospital, institution, clinical laboratory, or other facility used by the OTP to provide the necessary medical and rehabilitative services.
- The name and address of any facility other than the primary dispensing site where methadone will be dispensed either on a regular basis or on weekends, and as a service to the treatment program.
- A copy of the medical director’s Drug Enforcement Administration (DEA) registration, state license, and 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 feasibility shall address the portion of the medical director’s time spent in the treatment of unrelated medical patients and memberships on boards and committees that compete for time allocated to the treatment programs.
- The name and state license number of all OTP personnel (other than program physicians) licensed by law to dispense narcotic drugs even if they are not, at present, responsible for administering or dispensing methadone at the program. These would include pharmacists, registered nurses, and licensed practical nurses.
- A tentative schedule showing dispensing hours, counseling hours, and hours to be worked by physicians, nurses, and counselors. Any work to be performed away from the primary dispensing site should also be stated. The program must be open for dispensing at least six days per week. Also, describe how the dispensing hours are adequate and will ensure quality of patient care per 42 CFR 8.12 (b).
- A list of the program’s funding sources, including the name and address of each governmental agency providing funds.
- A description of the number of patients that will be treated by the program when it is operating at capacity.
- An affirmative statement that the treatment program will use containers having safety closures for all take-home medication dispensed to outpatients.
- Acknowledgement that the medical director and/or program physician must register for an account on the SAMHSA OTP Extranet website to submit federal patient exception requests (Form SMA-168) online. Applicants may register for an extranet account at the SAMHSA OTP Extranet website. After the request is verified, the applicant will receive an email with a username and password for use of the website.
Step-by-Step Application Instructions for Provisional Certification
- 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 “Provisional Certification.”
- Using the format examples as guidance, fill out all of the questions indicated with an asterisk. Failure to follow the required format will not allow the application to move forward.
- To continue, choose the “Next” button at the bottom of the page.
- Upload the 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 assistance, find the regional OTP Compliance Officer that you will be working with in your state.
Certification Renewal and Other Uses for Form SMA-162
Program sponsors must also use Form SMA-162 to renew certification for an existing OTP. Those program sponsors wishing to submit Form SMA-162 to renew their OTP certification must submit the form via their account on the SAMHSA OTP Extranet website. All OTPs have an account on the site.
Form SMA-162 is also used to:
- Notify SAMHSA of program changes, such as a change in medical director or program sponsor
- Apply to SAMHSA to receive approval for relocation or addition of a new medical unit (satellite clinic or mobile unit)
For instructions on accessing your program’s account, contact the SAMHSA OTP Extranet Information Center at:
- 866-OTP-CSAT (866-687-2728)
For more information about OTP certification and opening a treatment program, contact one of SAMHSA’s regional OTP Compliance Officers.