The Narcotic Addiction Treatment Act of 1974 and the Drug Addiction
Treatment Act of 2000 amended the CSA with respect to the use of controlled
substances in the medical treatment of addiction. These laws established the
procedures for approval and licensing of practitioners involved in the
treatment of opioid addiction as well as improving the quality and delivery of
that treatment to the segment of society in need.
Practitioners wishing to administer and dispense approved Schedule II
controlled substances (that is, methadone) for maintenance and detoxification
treatment must obtain a separate DEA registration as a Narcotic Treatment
Program. Application for registration as a Narcotic Treatment Program is made
using DEA Form 363. In addition to obtaining this separate DEA registration,
this type of activity also requires the approval and registration of the
Center for Substance Abuse Treatment (CSAT) within the Substance Abuse and
Mental Health Services Administration (SAMHSA) of the Department of Health and
Human Services (HHS), as well as the applicable state methadone authority.
If a practitioner wishes to prescribe, administer, or dispense Schedule
III, IV, or V controlled substances approved for addiction treatment (i.e.,
buprenorphine drug products), the practitioner must request a waiver (Form
SMA-167) and fulfill the requirements of CSAT. CSAT will then notify DEA of
all waiver requests. DEA will review each request. If DEA approves this
waiver, the practitioner will receive a Unique Identification Number. If a
practitioner chooses to dispense controlled substances, the practitioner must
maintain, separate from all other records, for a period of at least two years,
all required records of receipt, storage, and distribution. If a practitioner
chooses to prescribe these controlled substances, the practitioner must
utilize their Unique Identification Number on the prescription in addition to
his/her regular DEA registration number. The practitioner must also maintain a
record of each such prescription for a period of at least two years.
Practitioners should be aware that there may be limits on how many patients
they may treat for opioid addiction at any given time and should check with
SAMHSA to determine these limits.
Note that not all treatment programs utilize controlled substances, that
is, some are drug free. Accordingly, these activities do not require DEA
registration or approval.
Practitioners can find additional information regarding addiction treatment
by visiting DEA’s Office of Diversion Control website at
www.DEAdiversion.usdoj.gov. Click on "Publications," then
"Narcotic Treatment Programs: Best Practices Guidelines." The DEA
application Form 363 may be completed on-line.
To learn more about CSAT’s requirements, practitioners may visit one or
more of the following websites: www.samhsa.gov/centers/csat2002/csat_frame.html
, www.csat.samhsa.gov
, or www.buprenorphine.samhsa.gov
.
If the practitioner has a patient who is in need of addiction treatment, but
does not wish to treat the individual, the practitioner can refer the patient to
an existing facility through the following website: www.findtreatment.samhsa.gov.
