May 4, 2015
Opioid Treatment Programs and Related Federal Regulations
Federally certified opioid treatment programs (OTPs)—also
Regulatory Framework
called narcotic treatment programs or, often, methadone
clinics—may offer opioid medications, counseling, and
Two overlapping systems of federal law apply to MAT for
other services for individuals addicted to heroin or other
opioid addiction: one regulating pharmaceuticals and the
opioids. The use of opioid medications to treat opioid
other regulating controlled substances.
addiction is subject to federal regulations beyond those that
apply to the same medications used for other purposes (e.g.,
Federal Food, Drug, and Cosmetic Act (FFDCA)
treating pain). With few exceptions, the use of the opioid
medication methadone to treat opioid addiction is limited to
Under the Federal Food, Drug, and Cosmetic Act (FFDCA,
OTPs; however, physicians who wish to treat opioid
21 U.S.C. §§301 et seq.), the Food and Drug
addiction using the opioid medication buprenorphine may
Administration (FDA) in the Department of Health and
obtain a waiver to do so outside an OTP. A non-opioid
Human Services (HHS) has primary responsibility for
medication used in the treatment of opioid addiction,
ensuring the safety and effectiveness of pharmaceuticals,
naltrexone, may be used by OTPs, physicians with waivers,
regardless of whether they are controlled substances. See
or anyone with the authority to write prescriptions.
CRS Report R41983, How FDA Approves Drugs and
Regulates Their Safety and Effectiveness. Methadone,
To understand how OTPs are regulated, it is helpful to have
buprenorphine, and naltrexone are subject to the FFDCA.
some background information about the medications used
to treat opioid addiction and how each is regulated.
Controlled Substances Act (CSA)
Medication-Assisted Treatment (MAT)
Under the Controlled Substances Act (CSA, 21 U.S.C.
§§801 et seq.), the Drug Enforcement Administration
Medication-assisted treatment (MAT) is the combined use
(DEA) in the Department of Justice (DOJ) has primary
of medication and other services to treat addiction. Three
responsibility for regulating the use of controlled
medications are currently used in MAT for opioid
substances for legitimate medical, scientific, research, and
addiction: methadone, buprenorphine, and naltrexone.
industrial purposes, and for preventing these substances
from being diverted for illegal purposes. See CRS Report
Methadone
RL34635, The Controlled Substances Act: Regulatory
Requirements. Methadone and buprenorphine are subject to
Methadone is a full opioid agonist, meaning it binds to and
the CSA. Naltrexone, which carries no known risk of abuse,
activates opioid receptors in the brain. Methadone carries
is not.
risk of abuse but is less addictive than some other full
opioid agonists (e.g., heroin). Methadone suppresses
As shown in Table 1, methadone, buprenorphine, and
withdrawal symptoms in detoxification therapy and controls
naltrexone are classified differently under the CSA, which
the craving for opioids in maintenance therapy.
assigns various plants, drugs, and chemicals to one of five
schedules based on accepted medical use, potential for
Buprenorphine
abuse, and severity of potential psychological or physical
dependence. Schedule I contains substances that have no
Buprenorphine is a partial opioid agonist, meaning it binds
currently accepted medical use and are not available by
to opioid receptors in the brain and activates them, but not
prescription (such as heroin). Schedules II, III, IV, and V
as much as full opioid agonists. Buprenorphine carries risk
include substances that have recognized medical uses and
of abuse but is less addictive than methadone. Like
are progressively less dangerous and addictive.
methadone, buprenorphine is used for detoxification and
maintenance therapy.
Table 1. FDA-Approved Medications for Opioid MAT
Naltrexone
Medication Class CSA
Schedule
Methadone
Full Opioid Agonist
II
Naltrexone is an opioid antagonist, meaning it binds to
opioid receptors but does not activate them; it prevents
Buprenorphine Partial Opioid Agonist III
opioid agonists from binding to and activating opioid
Naltrexone Opioid
Antagonist none
receptors. Naltrexone carries no known risk of abuse.
Naltrexone is used for relapse prevention because an
Source: Prepared by the Congressional Research Service based on
individual on naltrexone who uses opioids will not
information publicly available from FDA and DEA.
experience their effects.
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Opioid Treatment Programs and Related Federal Regulations
Opioid Treatment Programs (OTPs)
DATA-Waived Physicians (DWPs)
Under the Controlled Substances Act, responsibility for
Physicians who wish to treat opioid addiction using the
regulating OTPs falls to both DEA in DOJ and the
opioid medication buprenorphine may obtain a waiver to do
Substance Abuse and Mental Health Services
so outside an OTP under the Drug Addiction Treatment Act
Administration (SAMHSA) in HHS. Opioid treatment
of 2000 (DATA 2000, P.L. 106-310). DATA 2000 waives
programs must obtain
the statutory requirement for separate DEA registration as
•
an OTP—and the corresponding regulatory requirements
accreditation from a SAMHSA-approved accreditor,
for accreditation and certification—if both the practitioner
• certification from SAMHSA, and
and the medication meet specified conditions.
• registration from DEA.
Practitioner Requirements
Programs meeting all requirements may “administer or
dispense directly (but not prescribe)” methadone,
To qualify for a waiver, a practitioner must notify the HHS
buprenorphine, and any other drug approved by FDA for
Secretary of the intent to use opioid replacement and must
such use. They may also administer a drug being studied for
certify that he or she is a qualifying physician, has the
treatment of opioid addiction in compliance with an FDA-
capacity to refer patients for appropriate counseling and
approved investigational new drug application.
other services, and will comply with a limit on the number
of patients. A qualifying physician must be licensed under
With few exceptions, the use of methadone to treat opioid
state law and have expertise as evidenced by certification,
addiction is limited to OTPs, which may also offer other
training, or experience. The limit is 30 patients during the
MAT, including buprenorphine for detoxification or
first year and may increase to 100 after one year, upon
maintenance and naltrexone for relapse prevention.
submission of a second notice to the Secretary (per the
OTP Accreditation
Office of National Drug Control Policy Reauthorization Act
of 2006, P.L. 109-469). Nearly 30,000 physicians have
DATA waivers.
Accreditation is based on a peer review process in which
SAMHSA-approved accrediting organizations evaluate
Medication Requirements
OTPs by making site visits and reviewing policies,
procedures, and practices. Examples of accrediting
organizations include the Joint Commission and the
DATA-waived physicians (DWPs) may administer,
dispense, or prescribe opioid replacement therapy using a
Commission on Accreditation of Rehabilitation Facilities.
medication that is a narcotic drug in schedule III–V, that is
OTP Certification
FDA-approved for use in detoxification or maintenance
treatment, and that has not been the subject of an adverse
determination (as defined in statute). Buprenorphine is the
Certification is based on SAMHSA’s determination that an
only medication to meet the conditions for a DATA waiver.
accredited program is qualified to carry out treatment
DEA assigns each DATA-waived physician a special
conforming to standards in federal regulation. SAMHSA
identification number, which must be included (along with
uses the results of the accreditation process as well as other
the physician’s regular DEA registration number) on all
information to determine whether a program is qualified.
buprenorphine prescriptions for opioid addiction therapy.
SAMHSA promulgates guidelines to help accrediting
organizations and OTPs conform to treatment standards.
Table 2 summarizes who can administer, dispense, or (in
OTP Registration
some cases) prescribe different types of MAT.
Table 2. MAT Used by OTPs, DWPs, and Others
Registration with DEA as an OTP is separate from—and in
addition to—the DEA registration required of any “person”
Used to Treat Opioid Addiction by
(including a hospital, pharmacy, or doctor, among others)
who handles controlled substances. Opioid treatment
Other
programs must also comply with relevant DEA regulations
Medication
OTPs DWPs
Prescribers
addressing records maintenance, security controls, and
other matters.
Methadone Yes
No No
Most U.S. substance abuse treatment facilities (91%) do not
Buprenorphine Yes Yes
No
have OTPs. As of March 29, 2013, the 1,282 facilities with
Naltrexone
Yes
Yes
Yes
OTPs had 330,308 clients in treatment with methadone.
Opioid treatment programs generally administer methadone
Source: Prepared by the Congressional Research Service based on
on a daily basis with staff observing as a patient takes an
21 U.S.C. §§801 et seq. and information publicly available from FDA.
oral dose of liquid methadone; however, a stable patient
Erin Bagalman, ebagalman@crs.loc.gov, 7-5345
may receive a few take-home doses (e.g., for a weekend).

IF10219
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