Opioid Treatment Regulation

Overview

In the U.S., treatment of opioid dependence with opioid medications is governed by Federal Regulation 42 CFR Part 8, dated January 17, 2001. The regulation provides for an accreditation and certification-based system for Opioid Treatment Programs (OTPs), overseen by SAMHSA. The Administrator of SAMHSA has delegated certain of these oversight responsibilities to the Center For Substance Abuse Treatment (CSAT), and within CSAT, to the Division of Pharmacologic Therapies (DPT).

The new Regulation acknowledges that addiction is a medical disorder not amenable to one-size-fits-all treatment. It recognizes that different patients, at different times, could need vastly different services. The Regulation enables DPT to focus its oversight efforts on improving treatment rather than soley ensuring that programs are meeting regulatory criteria.

The Regulation preserves States' authority to regulate OTPs. Oversight of treatment medications remains a tripartite system involving States, DHHS/SAMHSA, and the U.S. Department of Justice/DEA.

OTP Accreditation

Accreditation is a peer-review process that evaluates an OTP against SAMHSA's opioid treatment standards and accreditation standards of SAMHSA-approved accrediting bodies. It includes site visits by specialists with experience in opioid pharmacotherapy and related activities. For more information on OTP accreditation and designation as a SAMHSA-approved OTP accrediting body, view the OTP Accreditation page. A discusson of and links to two studies of the impact of OTP accreditation is found on the OTP Accreditation Impact Studies page.

OTP Certification

Once an OTP is accredited by a SAMHSA-approved accrediting body, SAMHSA uses the accreditation results along with other data to determine whether the program is qualified to carry out treatment under the standards in the regulations. Qualified programs receive certification by SAMHSA.

OTPs apply to SAMHSA for certification using the SMA-162 form. The SMA-162 form should also be used by OTPs for the following purposes:

• To apply to SAMHSA for renewal of certification of an OTP
• To notify SAMHSA of change of Program Sponsor
• To notify SAMHSA of change of Medical Director
• To apply to SAMHSA for relocation
• To apply to SAMHSA for addition of new medical unit (satellite clinic or mobile unit)

For more information on OTP certification and using the SMA-162 form, view the OTP Certification page.

Patient Exception Requests

Section 8.12 of the Federal regulation 42 CFR sets forth standards for the administration and management of opioid treatment under the regulations. Included in these standards are protocols for allowable take-home dosing, based on time in treatment and other factors. Additionally, protocols are set forth on the maximum number of allowable detoxification attempts within a one-year period.

On occasion, patients may need exceptions from the Federal opioid treatment standards due to transportation hardships, employment, vacation, medical disabilities, etc. In these instances, the physician must submit to SAMHSA and (where applicable) the State Opioid Treatment Authority an "exception request" for approval to change the patient care regimen from the requirements specified in Regulation 42 CFR part 8. Patient exception requests are submitted to SAMHSA using the SMA-168 form. SMA-168s can be submitted by fax or online.

Patient exception requests are reviewed for SAMHSA approval under the exemption provisions detailed in 42 CFR § 8.11(h). For more information on submitting patient exception requests, view the Exception Request page.

Buprenorphine

The Drug Addiction Treatment Act of 2000 expands the clinical context of medication-assisted opioid addiction treatment by allowing qualified physicians to dispense or prescribe specifically approved Schedule III, IV, and V narcotic medications for the treatment of opioid addiction in treatment settings other than the traditional OTP setting. In addition, DATA 2000 reduces the regulatory burden on physicians who choose to practice opioid addiction therapy by permitting qualified physicians to apply for and receive waivers of the special registration requirements defined in the Controlled Substances Act. For more information about buprenorphine and office-based opioid treatment, view the SAMHSA Buprenorphine Web site.

Guidance to OTPs

View the Guidance to OTPs page for recent and past communications from SAMHSA to the opioid treatment community regarding opioid treatment clinical and regulatory issues.

Regulations and Legislation

View the Regulations and Legislation page for links to federal opioid treatment regulations, legislation, and federal register notices.

OTP Directory

View the OTP Directory page for a list of all active opioid treatment programs, searchable by state and territory.

State Opioid Treatment Authority Directory

View the State Opioid Treatment Authorities page for contact information for State Opioid Treatment Authorities.