Legislation, Regulations, and Guidelines

Learn about the federal legislation, regulations, and guidelines that apply to opioid treatment programs (OTPs) and medication-assisted treatment (MAT).

Federal legislation, regulations, and guidelines govern medication-assisted treatment (MAT) for opioid addiction. SAMHSA’s Division of Pharmacologic Therapies (DPT), part of the SAMHSA Center for Substance Abuse Treatment (CSAT), oversees accreditation standards and certification processes for opioid treatment programs (OTPs). DPT also works with the Drug Enforcement Administration (DEA) and the states to regulate certain medications used in MAT. Additionally, DPT works directly with MAT professionals to improve treatment outcomes and to meet regulatory criteria.

MAT Legislation

Some medications used in MAT 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.

Drug Addiction Treatment Act of 2000 (DATA 2000)

DATA 2000, part of the Children’s Health Act of 2000, permits physicians who meet certain qualifications to treat opioid dependency with narcotic medications approved by the Food and Drug Administration (FDA)—including buprenorphine—in treatment settings other than OTPs.

The Act permits qualified physicians to obtain a waiver from the separate registration requirements of the Narcotic Addict Treatment Act – 1974 (PDF | 437 KB) to treat opioid dependency with Schedule III, IV, and V medications or combinations of such medications that have been approved by FDA for that indication. Learn more about buprenorphine to treat substance use disorders.

OTP Regulations

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 narcotic drugs to treat opioid dependency. The regulation shifted administrative responsibility and oversight of these treatments from FDA to SAMHSA.

The regulations acknowledge that opioid addiction 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 MAT remains a multilateral system involving states, SAMHSA, the Department of Health and Human Services (HHS), the Department of Justice (DOJ), and 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.

Read the final rule by SAMHSA regarding Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction – 2001.

MAT patients are also required to receive counseling, which could include 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 (PDF | 547 KB). 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 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 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.

Dear Colleague Letters

SAMHSA’s Dear Colleague Letters for MAT providers offer regular communications to the opioid treatment community regarding clinical and regulatory issues related to opioid treatment.

Special Circumstances for Providing Buprenorphine

Several federal laws and regulations permit physicians and other medical personal to administer buprenorphine to patients with opioid dependencies without a buprenorphine waiver under special circumstances.

Last Updated: 03/04/2019