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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

  • Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Repeal of Current Regulations and Issuance of New Regulations: Delay of Effective Date and Resultant Amendments to the Final Rule
    The 2001 final rule by SAMHSA repealed the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and created a new regulatory system based on an accreditation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.
     
  • 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 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”.
     
  • 42 Code of Federal Regulations (CFR) Part 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), and Drug Enforcement Administration (DEA).
     
  • 42 Code of Federal Regulations (CFR) Part 2
    On February 8, 2024, the U.S. Department of Health & Human Services, through the Substance Abuse and Mental Health Services Administration and the Office for Civil Rights announced a final rule modifying the Confidentiality of Substance Use Disorder Patient Records regulations at 42 CFR part 2. With this final rule, HHS implements the confidentiality provisions of section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (PDF | 855 KB) (enacted March 27, 2020), which required the Department to align certain aspects of Part 2 with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Rules and the Health Information Technology for Economic and Clinical Health Act (HITECH).

Guidelines and Guidance

Last Updated: 11/05/2024
Source: https://www.samhsa.gov/substance-use/treatment/statutes-regulations-guidelines