Opioid Treatment Program Certification

Overview

Certification is the process by which the SAMHSA/CSAT Division of Pharmacologic Therapies (DPT) determines that an OTP is qualified to provide opioid treatment under 42 CFR Part 8.

To obtain SAMHSA certification OTPs must successfully complete the accreditation process and meet other requirements enumerated in 42 CFR Part 8. A program may apply to SAMHSA for provisional (initial) certification during the time it is working towards accreditation with a SAMHSA-approved accrediting body. Provisional certification is a temporary certification granted for up to one year to a new OTP during which time it must become accredited.

Upon achieving accreditation a provisionally certified OTP may apply to SAMHSA for renewal (full) certification. Once certified, programs must renew certification at least every three years. For an overview of the OTP accreditation and certification processes, view the Opioid Treatment Regulation page.

Programs applying for accreditation or certification must also comply with the applicable statutes and regulations in their states. Contact information for State Opioid Treatment Authorities can be found on the State Opioid Treatment Authority page.

Applying to SAMHSA for Initial or Renewal OTP Certification

Application to SAMHSA for provisional (initial) certification of a new OTP, or renewal certification of an existing OTP, is made using Form SMA-162, Application for Certification to Use Opioid Drugs in Treatment.

Follow the appropriate link below for information on:

• Certification of a New OTP
  
  
• Re-Certification of an Existing OTP

Notifying SAMHSA of Program Changes

Existing OTPs must notify SAMHSA within 3 weeks of either of the following program changes:

• Change of Program Sponsor
• Change of Medical Director

In addition, existing OTPs must apply to SAMHSA to receive approval for:

• Relocation
• Addition of new medical units (satellite clinics or mobile units)

Additional information about notifying SAMHSA of program changes is available on the instruction page.

For More Information

For more information about OTP certification and opening a treatment program

In states beginning in A-FL, contact

• Mary Lou Ojeda
  Public Health Advisor
  Division of Pharmacologic Therapies
  SAMHSA Center for Substance Abuse Treatment
  mary.ojeda@samhsa.hhs.gov
  Voice: 240.276.2894
  Fax: 240.276.2710

In states beginning in GA-MI, contact

• Brandon Johnson
  Public Health Advisor
  Division of Pharmacologic Therapies
  SAMHSA Center for Substance Abuse Treatment
  brandon.johnson@samhsa.hhs.gov
  Voice: 240.276.2889
  Fax: 240.276.2889

In states beginning in MN-OH, contact

• Nichole Washington Smith
  Public Health Advisor
  Division of Pharmacologic Therapies
  SAMHSA Center for Substance Abuse Treatment
  nichole.washington@samhsa.hhs.gov
  Voice: 240.276.2719
  Fax: 240.276.2710

In states beginning in OK-WY, contact

• Steve Mason
  Public Health Advisor
  Division of Pharmacologic Therapies
  SAMHSA Center for Substance Abuse Treatment
  steve.mason@samhsa.hhs.gov
  Voice: 240.276.2901
  Fax: 240.276.2710

The mailing address for the above listed personnel is:

• Division of Pharmacologic Therapies
  Center for Substance Abuse Treatment
  SAMHSA
  1 Choke Cherry Rd.
  Rockville, MD 20857
  (Overnight: 20850)

SMA-162 forms can completed in paper form and faxed or mailed to SAMHSA and (where applicable) the State Opioid Treatment Authority.

• Download SMA-162: Application for Certification to Use Opioid Drugs in a Treatment Program Under 42 CFR 8.11
  (PDF, 129 KB)

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