Executive Summary

The role of Federal and State agencies in approving, monitoring, and setting policy for narcotic treatment programs is 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 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 the 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).

Given that there are many Federal and State agencies involved in regulating, monitoring, researching, funding, and providing assistance to narcotic treatment programs, "who does what" can be very confusing. Yet, understanding the roles of the various agencies is the key to operating your program according to the established standards. The responsibilities for approving and disapproving, monitoring, and setting standards for narcotic treatment programs are shared by the State and Federal agencies.

State approval and monitoring regulations must be at least as restrictive as the Federal regulations, but States may have any other regulations that fall within the authority of State law, as long as there is no conflict between Federal and State laws that prevents the two from standing together. For instance, many States have developed standards more stringent than the Federal regulations alone.

To permit a narcotic treatment program to operate in a State, that State is required by the FDA methadone regulations to designate a State Authority (SA) whose major role is to review each program application and determine the need for approving and disapproving narcotic treatment programs within the State. The need for a program is based on its proposed proximity to other programs and service need in the proposed location.

The SA collaborates with FDA and the Drug Enforcement Administration (DEA) to ensure that a proposed program meets minimum quality standards. SA representatives are allowed to inspect programs for compliance with regulatory standards and, if necessary, to recommend revocation of approval to FDA. In addition, FDA and DEA cannot approve an application unless the SA concurs.

In partial fulfillment of its responsibilities under the Federal Food, Drug, and Cosmetics Act, FDA, which is situated within the Department of Health and Human Services (DHHS), must ensure the safety and effectiveness of narcotic drugs. Within FDA this responsibility is delegated to the Center for Drug Evaluation and Research. Day-to-day responsibilities are conducted by the Division of Scientific Investigations, Regulatory Management Branch, which is responsible for confirming that all programs using narcotics are in compliance with Federal narcotic treatment regulations for maintenance and detoxification. It is this entity within the FDA that has the authority to approve or disapprove an application to establish a narcotic treatment program. Using procedures developed specifically for narcotic treatment programs, FDA field investigators monitor program services by conducting periodic inspection site visits.

Like FDA, DEA, under its Office of Diversion Control, will conduct program site visits to monitor compliance with controlled substance laws. DEA is situated within the Department of Justice and with the Narcotic Addict Treatment Act of 1974, became responsible for registering narcotic treatment programs that use methadone (or other approved narcotic drugs) in the treatment of narcotic addiction. DEA also ensures that programs are in compliance with controlled substance laws and requires registration of all programs in addition to the usual registration of physicians and pharmacists to prescribe, compound, or dispense controlled substances.

A further result of the 1974 Narcotic Addict Treatment Act was the collaboration of the National Institute on Drug Abuse (NIDA) and FDA to develop medical standards for using narcotic medications to treat narcotic addiction. Now a part of the National Institutes of Health (NIH), NIDA's role is to conduct research on the effectiveness of narcotic drugs for maintenance and detoxification, and quality-of-service issues. NIDA then makes the information on these research findings available to the other Federal agencies. In this way, NIDA-supported research contributes to revisions of standards that are made in the interest of improving the quality of treatment services.

Improving treatment services for individuals who abuse drugs is the principal function of the Center for Substance Abuse Treatment (CSAT) of the Substance Abuse and Mental Health Services Administration (SAMHSA). As with FDA, DEA, and NIDA, CSAT works with SAs and other Federal agencies to identify programmatic and systemwide issues that require technical assistance or training interventions. CSAT provides financial support through several different grant programs to meet the local or regional needs of targeted areas and special populations. In addition, CSAT has undertaken a number of initiatives designed to assist interested parties in developing and evaluating narcotic treatment services and in improving the quality of existing programs.

Copies of the pertinent Federal regulations are provided in this guide as appendices, along with sample forms. These exhibits are included to assist the reader in understanding the regulations and application process. However, nothing in this guide should be construed as authorizing or permitting any person to perform an act that is not permitted under the regulations governing narcotic treatment programs as cited throughout the guide, or by any other Federal and State laws.

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