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DEA Requirements for DATA-Waived Physicians
(DWPs): Practitioners Who Treat Narcotic Addiction Using
Buprenorphine
This document provides guidance to physicians who treat
narcotic addiction using buprenorphine drug products, schedule
III controlled substances, in the treatment of narcotic
dependence. On October 17, 2000, Congress passed the Drug
Addiction Treatment Act (DATA) which permits qualified
physicians to treat narcotic dependence with schedules III-V
narcotic controlled substances that have been approved by the
Food and Drug Administration (FDA) for that indication. At this
time, the only controlled substances approved for such use are
Subutex® and Suboxone®.
The legislation waives the requirement for obtaining a
separate DEA registration as a Narcotic Treatment Program (NTP)
for qualified physicians administering, dispensing, and
prescribing these specific FDA approved controlled substances.
Physicians registered with the Drug Enforcement Administration (DEA)
as practitioners who apply and are qualified pursuant to DATA
are issued a waiver (DWP) and will be authorized to conduct
maintenance and detoxification treatment using Subutex® and
Suboxone® without a NTP registration. DATA waivers are only
granted to qualified physicians. Hospitals and mid-level
practitioners do not qualify under the DATA.
DATA-waived physicians may treat thirty (30) or one hundred
(100) patients at any one time, dependent on individual
authorization from the Center for Substance Abuse Treatment (CSAT).
Physicians who submitted the notification for initial
authorization at least one year prior may submit a second
notification of the need and intent to increase the patient
limit from 30 patients up to 100 patients. Upon authorization by
CSAT, DEA will issue a new DEA certificate of registration with
a business activity code to identify whether the physician is
authorized to treat 30 or 100 patients.
Under the authority of the Controlled Substances Act CSA (21
U.S.C. 822 (f)), DEA is authorized to conduct periodic
on-site inspections of all registrants. DWPs are also subject to
on-site inspections to ensure compliance with the DATA and its
implementing regulations.
Physicians authorized to prescribe, administer, or dispense
approved schedule III-V controlled substances for maintenance
and detoxification should refer to the following Code of Federal
Regulations (CFR) sections:
- Persons required to keep records and file reports, 21
CFR 1301.28(d)(3), 1304.03(c),
1304.03(d), 1304.22(c)
and 1306.05(a)
- Maintenance of records, reports, and inventories, 21
CFR 1304.04
- Security, 21
CFR 1301.71, 1301.75(b)
and 1301.76
- Thefts involving controlled substances, 21 CFR 1301.76(d)
- Disposal of controlled substances, 21
CFR 1307.21
DWPs should also refer to the following websites for
additional information:
- Substance Abuse and Mental Health Services Administration
(SAMHSA) Website: www.buprenorphine.samhsa.gov
- DEA Website: www.DEAdiversion.usdoj.gov
Questions regarding the DATA and other narcotic addiction
treatment issues may be addressed to the Office of Diversion
Control, Liaison and Policy Section, at (202) 307-7297.
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