Federal Regulations for Opioid Treatment Programs
The grid below provides an overview of federal regulations related to the establishment of opioid treatment programs (OTPs) or the provision of methadone treatment. Our Program Assistance is available for questions (1-844-263-8762/1-844-COE-URMC).
Learn more about the Rural Opioid and Direct Support Services (ROADSS) program.
| Required Federal Regulations | ||
|---|---|---|
| Source/Agency | Description | Link |
| Substance Abuse and Mental Health Services Administration (SAMHSA) | Regulations outlining how an OTP can register to administer or dispense medications for opioid use disorder. | Federal Guidelines for Opioid Treatment Programs (January 2015) |
| Drug Enforcement Administration (DEA) | Additional regulations related to registration for the manufacturers, distributors, and dispensers of controlled substances along with applications and protocols. | CFR Title 21: Food and Drugs (updated regularly) |
| Additional Resources | ||
| Code of Federal Regulations (CFR) | Up-to-date online tool; official legal print publication published by the federal government. | CFR Title 42: Public Health CFR (updated regularly) |
| SAMHSA | Guide to the three approved medications for opioid use disorder. | Treatment Improvement Protocol TIP 63 (updated 2021) |
| American Society of Addiction Medicine (ASAM) | Guideline on implementing best practices for the treatment of opioid use disorder. | National Practice Guideline for the Treatment of Opioid Use Disorder (updated 2020) |
Updated July 2024