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RCORP - Rural Center of Excellence on SUD Prevention

Federal Regulations for Opioid Treatment Programs (ROADSS)

The grid below provides an overview of the federal regulations and links to the state guidelines for Kentucky, New York, Ohio, and West Virginia, the states where UR Medicine Recovery Center of Excellence is working with 23 specific counties to address the opioid crisis. It identifies the specific regulations related to the establishment of Opioid Treatment Programs (OTPs) or the dispensing of methadone treatment. Our Technical Assistance Center is available for questions (1-844-263-8762/1-844-COE-URMC).

Required Federal Regulations
Agency Description of Link Direct Link to Regulation

SAMHSA (Substance Abuse and Mental Health Services Administration)

The SAMHSA document includes federal regulations that outline how an OTP can register to administer or dispense medications for opioid use disorder (MOUD).

Federal Guidelines for Opioid Treatment Program, January 2015

DEA (Drug Enforcement Administration)

The DEA link lists additional federal regulations that relate to registration for the manufacturers, distributors, and dispensers of controlled substances along with applications and protocols.

Title 21: Code of Federal Regulations from the U.S. Department of Justice DEA Diversion Control Division

Additional Federal Resources

Code of Federal Regulations (CFR)

The CFR link is an up-to-date online tool includes the official legal print publication published by the federal government.

Title 42: Public Health in the CFR

Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs

The guide includes best-practice from the “front-line” to improve substance use treatment.

A Treatment Improvement Protocol TIP 43; developed by SAMHSA

American Society of Addiction Medicine (ASAM)

Guidelines for the treatment of opioid use disorder (OUD). A robust best practice document for treating OUD including the use of methadone maintenance treatment.

The National Practice Guideline for the treatment of OUD developed by ASAM