Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Practitioner's Manual - SECTION VI


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 Diversion Control Division website at www.DEAdiversion.usdoj.gov. Click on "Publications," then "Narcotic Treatment Programs: Best Practices Guidelines." The DEA application Form 363 may be completed online.

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

Section V Table of Contents | Appendices

Practitioner's Manual (PDF)


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