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 (SUDs). New federal regulations transferred administrative responsibility over the use of opioid medications in maintenance and detoxification treatment of SUDs from the Food and Drug Administration (FDA) to SAMHSA (see Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8).
In addition, the regulations established procedures to approve nonprofit groups or state governmental entities to become a SAMHSA-approved accrediting body.
SAMHSA-approved accrediting bodies evaluate opioid treatment programs (OTPs) and perform an accreditation survey to ensure SAMHSA’s opioid use disorder (OUD) 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.
To assist accrediting organizations and OTPs to achieve regulatory compliance, SAMHSA developed Federal Guidelines for Opioid Treatment Programs.
New and Renewal Applications
All new and renewal applicants must submit Form SMA-163: Application for Approval as Accreditation Body.
New applicants can submit their SMA-163 online. Previously approved entities seeking renewal must submit their SMA-163 through their account on the SAMHSA OTP Extranet Website. 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
Form SMA-163 includes a list of documents required for submission with the application. These documents should be prepared as file attachments to the online form. No applications will be reviewed until all required documentation is submitted.