Oversight of Opioid Treatment Program (OTP) Accrediting Bodies

Nonprofit groups or state governmental entities can apply for approval to accredit opioid treatment programs (OTPs).

In 2001, the Department of Health and Human Services (HHS) and SAMHSA issued final regulations to establish a new oversight system for the treatment of substance use disorders with medication-assisted treatment (MAT). New federal regulations transferred administrative responsibility over the use of opioid medications in maintenance and detoxification treatment of substance use disorders from the Food and Drug Administration (FDA) to SAMHSA (see Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8). They also established procedures for an entity to become an approved accrediting body. These entities must be nonprofit accreditation organizations or state governmental entities. SAMHSA-approved accrediting bodies evaluate OTPs and perform site visits to ensure SAMHSA’s opioid dependency treatment standards are met.

SAMHSA’s Division of Pharmacologic Therapies (DPT) provides guidance to entities that wish to participate in SAMHSA’s OTP certification program and become an accreditor of OTPs. Learn more about the certification of OTPs.

Initial and Renewal Applications to be a SAMHSA-Approved OTP Accrediting Body

New applicants must use Form SMA-163: Application for Approval as Accreditation Body.

Entities that have previously been approved as an accrediting body and are seeking renewal must also submit Form SMA-163 online. Renewal of SAMHSA approval is required every five years.

The following information is required on all SMA-163 forms:

  • Purpose of application (new or renewal)
  • Accreditation body name
  • Accreditation body address
  • Responsible official name
  • Responsible official address and contact information

Online Form SMA-163 also indicates a list of additional required documents. These documents should be prepared as file attachments to the online form.

SAMHSA will not begin processing a submitted Form SMA-163 until all required documentation is received.

Accreditation Guidelines

The Guidelines for the Accreditation of Opioid Treatment Programs were first released in 1999 to provide direction to accrediting organizations and OTPs on achieving regulatory compliance. These guidelines are reviewed and updated regularly. Access the most recent version of the Federal Guidelines for Opioid Treatment Programs – 2015.

Additional Assistance

For more information about becoming a SAMHSA-approved OTP accrediting body, contact:

Ann Rodrigues, JD, MHA
Public Health Advisor
Division of Pharmacologic Therapies
Center for Substance Abuse Treatment

Contact SAMHSA

Last Updated: 11/09/2018