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Statutes, Regulations, and Guidelines

Statutes

  • Controlled Substances Act
    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.
  • Training Requirements (MATE Act) Resources
    Section 1263 of the Consolidated Appropriations Act of 2023 requires that beginning June 27, 2023, practitioners applying for a new or renewed Drug Enforcement Administration (DEA) registration will need to attest to having completed a total of at least 8 hours of training on opioid or other substance use disorders, as well as the safe pharmacological management of dental pain.
  • Waiver Elimination (MAT Act)
    Section 1262 of the Consolidated Appropriations Act, 2023 (also known as Omnibus bill), removes the federal requirement for practitioners to submit a Notice of Intent (have a waiver) to prescribe medications, like buprenorphine, for the treatment of opioid use disorder (OUD).

Regulations

  • Revised 42 Code Federal Regulations (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 FDA-approved 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”.

    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), and Drug Enforcement Administration (DEA).

  • 42 Code of Federal Regulations (CFR) Part 2
    Part 2 is a federal law (42 U.S.C. 290dd-2 and 42 CFR part 2) that protects the confidentiality of patient records for people receiving services for substance use disorders (SUDs). Part 2 confidentiality rules describe when and how SUD patient records may be used and disclosed. These records are called Part 2 records.

    Part 2 rules apply to any federally assisted program that provides SUD diagnosis, treatment, or referral for treatment. These programs are called Part 2 programs. Some Part 2 requirements also apply to people and organizations who receive Part 2 records, such as other health care providers, Qualified Service Organizations (QSOs), HIPAA covered entities and business associates, intermediaries, and investigative agencies.

Guidelines and Guidance

Last Updated: 02/17/2026
Source: https://www.samhsa.gov/substance-use/treatment/statutes-regulations-guidelines