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. (SAMHSA certification is comparable to the former FDA approval, which authorized OTPs to provide treatment prior to May 18, 2001.)

In order to become certified by SAMHSA, OTPs must successfully complete the accreditation process and meet other requirements enumerated in 42 CFR Part 8. A program may apply to SAMHSA for initial 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 for a new OTP until it can become accredited. Upon achieving accreditation a provisionally certified OTP may apply to SAMHSA for full (or renewal) 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 Methadone Authorities can be found on the State Methadone Authorities page.

Application for Provisional and Renewal OTP Certification

Application to SAMHSA for provisional (initial) OTP certification and for renewal of certification is made using form SMA-162, Application for Certification to Use Opioid Drugs in Treatment. OTPs must also comply with their state and local laws and regulations regarding OTP accrediation and certification.

Notifying SAMHSA of Program Changes

Once certified, OTPs must notify SAMHSA within 3 weeks of any of the following program changes when they occur:

• Change of Program Sponsor
• Change of Medical Director

OTPs must apply to SAMHSA to receive approval for:

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

OTPs should use the SMA-162 form to notify SAMHSA of, or apply to SAMHSA for, the above program changes and applications.

Submit an SMA-162 Form

The SMA-162 form and supporting documents may be submitted to SAMHSA on-line, by fax, or by mail. For the fastest response, SAMHSA recommends on-line submission. SMA-162 forms must be signed by the Program Sponsor.

• Submit an SMA-162 form On-line
• Download an SMA-162 form to Fax or Mail (PDF, 55 KB)
• Download the Checklist for Completing the SMA-162 (PDF, 24 KB)

For More Information

For more information about OTP certification and opening a treatment program

In states beginning in A - I, contact

• Mary Lou Ojeda
  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 K - NV, contact

• Sara Azimi-Bolourian
  Public Health Advisor
  Division of Pharmacologic Therapies
  SAMHSA Center for Substance Abuse Treatment
  sara.azimi-bolourian@samhsa.hhs.gov
  Voice: 240.276.2708
  Fax: 240.276.2710

In states beginning in NY - WY, contact

• Sarah Crowley
  Public Health Advisor
  Division of Pharmacologic Therapies
  SAMHSA Center for Substance Abuse Treatment
  Sarah.Crowley@samhsa.hhs.gov
  Voice: 240.276.2704
  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)

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