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Updated June 26, 2018
Opioid Treatment Programs and Related Federal Regulations
Federally certified opioid treatment programs (OTPs)—
Regulatory Framework
often called methadone clinics—offer opioid medications,
counseling, and other services for individuals addicted to
Two overlapping systems of federal law apply to MAT for
heroin or other opioids. The use of opioid medications to
opioid addiction: one regulating pharmaceuticals and the
treat opioid addiction is subject to federal regulations
other regulating controlled substances.
beyond those that apply to the same medications used for
other purposes (e.g., treating pain). The medications
Federal Food, Drug, and Cosmetic Act (FFDCA)
methadone and buprenorphine are both opioids; their use to
Under the Federal Food, Drug, and Cosmetic Act (FFDCA,
treat opioid addiction is often called opioid substitution
21 U.S.C. §§301 et seq.), the Food and Drug
therapy or opioid replacement therapy. With few
Administration (FDA) in the Department of Health and
exceptions, the use of methadone to treat opioid addiction is
Human Services (HHS) has primary responsibility for
limited to OTPs; however, physicians who wish to treat
ensuring the safety and effectiveness of pharmaceuticals,
opioid addiction using buprenorphine may obtain a waiver
regardless of whether they are controlled substances. See
to do so outside an OTP. A non-opioid medication used in
CRS Report R41983, How FDA Approves Drugs and
the treatment of opioid addiction, naltrexone, may be used
Regulates Their Safety and Effectiveness. Methadone,
by OTPs, physicians with waivers, or anyone with the
buprenorphine, and naltrexone are subject to the FFDCA.
authority to write prescriptions.
Controlled Substances Act (CSA)
To understand how OTPs are regulated, it is helpful to have
Under the Controlled Substances Act (CSA, 21 U.S.C.
some background information about the medications used
§§801 et seq.), the Drug Enforcement Administration
to treat opioid addiction and how each is regulated.
(DEA) in the Department of Justice (DOJ) has primary
responsibility for regulating the use of controlled
Medication-Assisted Treatment (MAT)
substances for legitimate medical, scientific, research, and
industrial purposes, and for preventing these substances
Medication-assisted treatment (MAT) is the combined use
from being diverted for illegal purposes. See CRS Report
of medication and other services to treat addiction. Three
R45164, Legal Authorities Under the Controlled
medications are currently used in MAT for opioid
Substances Act to Combat the Opioid Crisis, by Brian T.
addiction: methadone, buprenorphine, and naltrexone
Yeh. Methadone and buprenorphine are subject to the CSA.
(naloxone, a medication used to reverse opioid overdose, is
Naltrexone, which carries no known risk of abuse, is not.
not used to treat opioid use disorders).
As shown in Table 1, methadone, buprenorphine, and
Methadone
naltrexone are classified differently under the CSA, which
Methadone is a full opioid agonist, meaning it binds to and
assigns various plants, drugs, and chemicals to one of five
activates opioid receptors in the brain. Methadone carries
schedules based on accepted medical use, potential for
risk of abuse but is less addictive than some other full
abuse, and severity of potential psychological or physical
opioid agonists (e.g., heroin). Methadone suppresses
dependence. Schedule I contains substances that have no
withdrawal symptoms in detoxification therapy and controls
currently accepted medical use and are not available by
the craving for opioids in maintenance therapy.
prescription (such as heroin). Schedules II, III, IV, and V
include substances that have recognized medical uses and
Buprenorphine
are progressively less dangerous and addictive.
Buprenorphine is a partial opioid agonist, meaning it binds
to opioid receptors in the brain and activates them, but not
Table 1. FDA-Approved Medications for Opioid MAT
as much as full opioid agonists. Buprenorphine carries risk
of abuse but is less addictive than methadone. Like
Medication
Class
CSA Schedule
methadone, buprenorphine is used for detoxification and
Methadone
Ful Opioid Agonist
II
maintenance therapy.
Buprenorphine
Partial Opioid Agonist
III
Naltrexone
Naltrexone
Opioid Antagonist
none
Naltrexone is an opioid antagonist, meaning it binds to
opioid receptors but does not activate them; it prevents
Source: Prepared by the Congressional Research Service based on
opioid agonists from binding to and activating opioid
information publicly available from FDA and DEA.
receptors. Naltrexone carries no known risk of abuse.
Naltrexone is used for relapse prevention because an
individual on naltrexone who uses opioids will not
experience the effects of that opioid.
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link to page 2 Opioid Treatment Programs and Related Federal Regulations
Opioid Treatment Programs (OTPs)
DATA-Waived Providers (DWPs)
Under the CSA, responsibility for regulating OTPs falls to
Under the Drug Addiction Treatment Act of 2000 (DATA
both DEA in DOJ and the Substance Abuse and Mental
2000, P.L. 106-310), a physician may obtain a waiver to
Health Services Administration (SAMHSA) in HHS. OTPs
treat opioid addiction with buprenorphine (but not
must obtain
methadone) outside an OTP. DATA 2000 waives the
requirement for separate DEA registration as an OTP if
accreditation from a SAMHSA-approved accreditor,
both the practitioner and the medication meet specified
conditions. As of May 1, 2018, the number of DATA-
certification from SAMHSA, and
waived providers exceeded 36,000; the number is updated
daily on SAMHSA’s website.
registration from DEA.
Practitioner Requirements
Programs meeting all requirements may “administer or
To qualify for a waiver, a practitioner must notify the HHS
dispense directly (but not prescribe)” any drug approved by
Secretary of the intent to use opioid replacement therapy
FDA for treatment of opioid addiction. They may also
and must certify that he or she is a qualifying physician
administer a drug being studied for treatment of opioid
(licensed under state law with expertise as evidenced by
addiction, as authorized by FDA under an investigational
certification, training, or experience); has the capacity to
new drug application.
refer patients for appropriate counseling and other services;
and will comply with a limit on the number of patients. The
With few exceptions, the use of methadone to treat opioid
patient limit is 30 during the first year, may increase to 100
addiction is limited to OTPs, which may also offer other
after one year (per the Office of National Drug Control
forms of MAT, including buprenorphine for detoxification
Policy Reauthorization Act of 2006, P.L. 109-469), and
or maintenance and naltrexone for relapse prevention.
may increase to 275 under conditions specified in
regulation (per 81 Federal Register 44711, July 8, 2016).
OTPs generally administer methadone on a daily basis with
staff observing as a patient takes an oral dose of liquid
The Comprehensive Addiction and Recovery Act (P.L.
methadone; however, a stable patient may receive a few
114-198) temporarily (through October 1, 2021) allows
take-home doses (e.g., for a weekend).
nurse practitioners or physician assistants meeting specified
criteria to obtain DATA waivers.
According to SAMHSA’s National Survey of Substance
Abuse Treatment Services, most U.S. substance abuse
Medication Requirements
treatment facilities (91%) do not have OTPs. As of March
DATA-waived providers (DWPs) may administer,
31, 2016, the 1,308 facilities with OTPs had 345,443 clients
dispense, or prescribe opioid replacement therapy using a
in treatment with methadone.
medication that is a narcotic drug in schedule III–V, that is
FDA-approved for use in detoxification or maintenance
OTP Accreditation
treatment, and that has not been the subject of an adverse
Accreditation is based on a peer review process in which
determination (as defined in statute). Buprenorphine is
SAMHSA-approved accrediting organizations evaluate
currently the only medication to meet the conditions for a
OTPs by making site visits and reviewing policies,
DATA waiver. DEA assigns each DATA-waived provider a
procedures, and practices. Examples of accrediting
special identification number, which must be included
organizations include the Joint Commission and the
(along with the provider’s regular DEA registration
Commission on Accreditation of Rehabilitation Facilities.
number) on all buprenorphine prescriptions for MAT.
OTP Certification
Table 2 summarizes who can administer, dispense, or (in
Certification is based on SAMHSA’s determination that an
some cases) prescribe different types of MAT.
accredited program is qualified to carry out treatment
conforming to standards in federal regulation. SAMHSA
Table 2. MAT Used by OTPs, DWPs, and Others
uses the results of the accreditation process as well as other
information to determine whether a program is qualified.
Used to Treat Opioid Addiction by
SAMHSA promulgates guidelines to help accrediting
organizations and OTPs conform to treatment standards.
Other
Medication
OTPs
DWPs
Prescribers
OTP Registration
Methadone
Yes
No
No
Registration with DEA as an OTP is separate from—and in
addition to—the DEA registration required of any “person”
Buprenorphine
Yes
Yes
No
(including a hospital, pharmacy, or doctor, among others)
who handles controlled substances. OTPs must also comply
Naltrexone
Yes
Yes
Yes
with relevant DEA regulations addressing records
Source: Prepared by the Congressional Research Service from 21
maintenance, security controls, and other matters.
U.S.C. §§801 et seq. and information publicly available from SAMHSA.
Johnathan H. Duff, Analyst in Health Policy
IF10219
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Opioid Treatment Programs and Related Federal Regulations
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