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.