42 CFR Part 8 Final Rule

Part 8 of Title 42 of the Code of Federal Regulations (CFR) includes the regulations that guide opioid treatment programs (OTPs); these went into effect in 2001. The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA) revised these regulations and released the final rule in February 2024.

The revisions take historic steps to increase access to lifesaving, evidence-based medications for opioid use disorder (MOUD) and to advance retention in care through promoting patient-centered and compassionate interventions. These rules went into effect on April 2, 2024 and the compliance date is October 2, 2024, allowing time for OTPs to prepare and for states to review their regulations that impact how this rule is implemented.

The final rule promotes practitioner autonomy, removes stigmatizing or outdated language, supports a patient-centered approach, and reduces barriers to receiving care. These elements were identified as being essential to promoting effective treatment in OTPs and reflect an OTP accreditation and treatment environment that has evolved over the past 20 years. In this way, final changes to Part 8 are responsive to the predominant concerns of OTP practitioners and patients.

SAMHSA will work with OTPs, SOTAs, and other stakeholders to assist with implementation of these final rules. If OTPs have questions regarding implementation of the final rule, please contact the designated Regional Compliance Officer. State Opioid Treatment Authorities and State Directors should contact the SAMHSA Division of Pharmacologic Therapies at 240-276-2700 or DPT@samhsa.hhs.gov.