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

Narcotic Treatment Programs Best Practice Guideline

PART 1

REGISTRATION

At present, registering to become a narcotic treatment program (NTP) involves the State Methadone Authority (SMA), the Food and Drug Administration (FDA), and the Drug Enforcement Administration (DEA). Registration requires approval from all three of these agencies.


Key Elements of the Registration Process

The registration process includes:

  • Submission of Completed Applications to SMA, FDA, and DEA
    • Contact the SMA for an application form and instructions and for information about applicable state regulations.
    • Contact FDA's Division of Scientific Investigations, Regulatory Management Branch, at 7520 Standish Place, Room 115, Rockville, MD 20855, Telephone number (888) 463-6332, for an application package for an NTP.
    • Contact the local DEA diversion field office to obtain the DEA application. (A copy of the DEA Form-363, "Application for Registration," is found in Appendix B. See Appendix D for a list of local DEA diversion field offices.)
  • Review of Applications by the SMA, FDA, and DEA
  • Pre-Registration Review and/or Inspection Conducted by the SMA, FDA, and DEA
    The SMA, FDA, and DEA each conduct a separate pre-registration review and/or inspection. The personnel conducting the inspections review relevant requirements with the applicant.
  • Approval
    DEA may approve an application if the NTP has met all CSA recordkeeping and security requirements. However, a certificate of registration will not be issued until the SMA and FDA have licensed the applicant.

Other Sources of Information

SMA, FDA, and DEA personnel are available to answer questions about the registration process and requirements. In addition, the Center for Substance Abuse Treatment (CSAT) has published a monograph, entitled "Approval and Monitoring of Narcotic Treatment. A Guide on the Roles of Federal and State Agencies (Technical Assistance Publication No. 12)," which describes the registration process in detail. For a copy of this document, contact the National Clearinghouse for Alcohol and Drug Information at PO Box 2345, Rockville, MD 20847-2345, Telephone number (800) 729-6686.

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