Opioid Treatment Regulation
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.
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.
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
For more information on OTP certification and using the SMA-162 form, view the OTP Certification page.
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.
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.
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.
View the Regulations and Legislation page for links to
federal opioid treatment regulations, legislation, and federal register notices.
View the OTP Directory page for
a list of all active opioid treatment programs, searchable by state and territory.
State Opioid Treatment Authorities page for contact information for State Opioid Treatment Authorities.