The Federal Guidelines for Opioid Treatment Programs (Guidelines) describe the Substance Abuse and Mental Health Services Administration’s (SAMHSA) expectation of how the federal opioid treatment standards found in Title 42 of the Code of Federal Regulations Part 8 (42 CFR § 8) are to be satisfied by opioid treatment programs (OTPs). Under these federal regulations, OTPs are required to have current valid accreditation status, SAMHSA certification, and Drug Enforcement Administration (DEA) registration before they are able to administer or dispense opioid drugs for the treatment of opioid addiction. As stated in 42 CFR § 8.12(i)(2), these regulations apply to “opioid agonist treatment medications that are approved by the Food and Drug Administration.” Currently, these drugs are methadone and pharmaceutical products containing buprenorphine, hereafter referred to as buprenorphine. The regulations apply equally to both of these medications, with the only difference being the time and treatment requirement for unsupervised dosing spelled out in 42 CFR § 8.12(i)(3). Other pharmacotherapies may be provided in a manner consistent with the best medical practices for each drug. For example, the use of naltrexone has a place in OTPs but is not subject to these regulations.
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- FEDERAL GUIDELINES FOR OPIOID TREATMENT PROGRAMS
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