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Statutes, Regulations, and Guidelines

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Learn about the federal statutes, regulations, and guidelines that apply to medications for practitioners and opioid treatment programs (OTPs).

Federal statutes, regulations, and guidelines govern medications for opioid addiction. SAMHSA’s Division of Pharmacologic Therapies (DPT), part of SAMHSA’s Center for Substance Abuse Treatment (CSAT), manages the day-to-day oversight activates required to implement federal regulations surrounding the use medications approved by the Food and Drug Administration (FDA) such as methadone and buprenorphine for the treatment of opioid use disorder (OUD) for practitioners and opioid treatment programs (OTPs).

Statutes related to Medications for Treatment of Opioid Use Disorders

Some medications used to treat substance use disorder (SUD) are controlled substances governed by the Controlled Substances Act. The Act contains federal drug policy for regulating the manufacture, importation, possession, use, and distribution of controlled substances.

OTP Regulations

The 2001 final rule by SAMHSA regarding Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction repealed the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and created a new regulatory system based on an accreditation model. It also shifted administrative responsibility and oversight of the program from FDA to SAMHSA.

The revised 42 CFR Part 8, Medications for the Treatment of Opioid Use Disorder, published on February 2, 2024. This final rule modifies, and updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of opioid use disorder (OUD) with medications for opioid use disorder (MOUD) in OTPs. This includes making flexibilities put forth during the COVID–19 Public Health Emergency (PHE) permanent, as well as expanding access to care and evidence-based treatment for OUD. The final rule also removes all language and rules pertaining to the Drug Addiction and Treatment Act (DATA) Waiver from the regulations pursuant to the “Consolidated Appropriations Act, 2023”.

Certification of Opioid Treatment Programs, 42 Code of Federal Regulations (CFR) 8 provides for an accreditation and certification-based system for OTPs, overseen by SAMHSA, and includes regulations for using opioid drugs to treat OUD. The regulation shifted administrative responsibility and oversight of these treatments from FDA to SAMHSA.

The regulations acknowledge that OUD is a medical disorder and that different patients, at different times, could need vastly different treatment services. The regulations also preserve states’ authority to regulate OTPs. Oversight of treatment medications used in MOUD remains a multilateral system involving states, SAMHSA, the Department of Health and Human Services (HHS), the Department of Justice (DOJ), and Drug Enforcement Administration (DEA).

Certification of Opioid Treatment Programs, 42 Code of Federal Regulations, Part 2 protects patient confidentiality through restrictions concerning the disclosure and use of patient records pertaining to substance use treatment.

MOUD patients receiving care in OTPs are also required to receive counseling, which includes different forms of behavioral therapy. Learn more about medication and counseling treatment.

Guidelines for Opioid Treatment

The Federal Guidelines for Opioid Treatment Programs – 2015 serve as a guide to accrediting organizations for developing accreditation standards. The guidelines also provide OTPs with information on how programs can achieve and maintain compliance with federal regulations. The 2015 guidelines are an update to the 2007 Guidelines for the Accreditation of Opioid Treatment Programs. The new document reflects the obligation of OTPs to deliver care consistent with the patient-centered, integrated, and recovery-oriented standards of substance use treatment.

DPT oversees the certification of OTPs and provides guidance to nonprofit organizations and state governmental entities that want to become a SAMHSA-approved accrediting body. Learn more about the accreditation and certification of OTPs and SAMHSA’s oversight of OTP accreditation bodies.

Model Guidelines for State Medical Boards

With input from SAMHSA, the Federation of State Medical Boards in 2013 adopted a revised version of the federation’s office-based opioid treatment policies. The Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office – 2013 (PDF | 279 KB) provides model guidelines for use by state medical boards in regulating office-based opioid treatment.

OTP Guidance

Methadone Take-Home Flexibilities Extension Guidance

Split Dose Guidance (PDF | 224 KB)
Guidance document on split dosing under the current take-home flexibilities.

Holiday Guidance for Opioid Treatment Programs (PDF | 203 KB)
In response to requests for the upcoming federal holidays and ensuing weekends (December 24th, 25th, and 26th and December 31st, Jan 1st, and Jan 2nd), this letter is to provide guidance regarding requests for unsupervised doses of medication for patients for these dates. View a sample SMA-168 (PDF | 194 KB).

Letter to OTP Directors, SOTAs and State Directors on Mobile Component (PDF | 216 KB)
Information regarding the authorization for Opioid Treatment Programs (OTPs) to add a “mobile component” to their existing registration. This is an opportunity to expand access to medications for treatment of Opioid Use Disorders (OUD), especially in remote or underserved areas.

Letter to State Substance Abuse Directors (PDF | 238 KB)
Letter from Miriam E. Delphin-Rittmon, Ph.D, Assistant Secretary for Mental Health and Substance Use, regarding funding for mobile medical units of Opioid Treatment Programs (OTPs).

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