Introduction

The roles of Federal and State agencies in approving, monitoring, and setting policy for narcotic treatment programs are sometimes confusing to individuals who want to sponsor the establishment of a narcotic treatment program. After reviewing some of the history of the involvement of Federal and State regulatory agencies in the treatment of opioid addicts, the guide offers a step-by-step overview. It covers the basics of what to expect from Federal and State agencies during the process of program approval and monitoring.

The term "narcotic treatment," which is uniformly used throughout this guide, is intended to refer to the use of a narcotic drug as the primary element of treatment. While methadone treatment is only one intervention in a spectrum of services available to persons with opioid addiction, it is currently the most frequently used substitution therapy. Thus the approval and monitoring procedures reviewed in this guide are applicable to methadone treatment; however, the same procedures are expected to be used by Federal and State regulatory agencies to approve programs using other opioid medication therapies, as they are approved by the Food and Drug Administration (FDA).

Use of the following features of the guide will help clarify the details of each topic reviewed:

• The side bars contain references from Federal regulations that are included as appendices. You can use the references to locate and review the standards for each topic.
• The exhibits amplify details and help clarify interpretations of the regulations. These are intended to assist you in developing solutions to problems; they are not mandated strategies.
• Copies of relevant portions of the Federal regulations are provided as appendices. They combine, in a single source, the most critical information necessary.
• Sample forms required for application are included to help you complete the actual application forms.

Back to Top