establishing the safety, effectiveness, and consistent quality that are applied to virtually all prescription drugs under the Federal Food, Drug, and Cosmetic Act. Second, because methadone is a legal narcotic drug, its production, distribution, and dispensing are subject to the requirements applied to schedule II controlled substances by the Drug Enforcement Administration (DEA) to prevent diversion and illicit use.

In the case of methadone, a unique third tier of special standards has been established by the Department of Health and Human Services (HHS) prescribing how and under what circumstances methadone may be used to treat opiate addiction. These standards are implemented by FDA regulations, jointly with the National Institute on Drug Abuse (NIDA) since 1980 and, since 1993, with the Substance Abuse and Mental Health Services Administration (SAMHSA.) The FDA regulations issued in 1972 were designed to create a special ''closed system'' of distribution and use of methadone for opiate addiction treatment, restricted to hospital pharmacies and to physicians registered with both FDA and DEA who were authorized to dispense the medication in a treatment program only. This three-tiered system of federal regulation has continued for over 20 years and has recently been extended to a methadone analog, levo-alpha-acetyl-methadol (LAAM). The basic assumptions of this system have not been reviewed comprehensively during this period.

Methadone treatment of opiate addiction is often restricted still further by many state governments, a fourth level of regulation, a matter beyond the scope of this report. To complicate the picture even further, a fifth tier of regulatory authority over methadone treatment programs is sometimes found at the county and municipal level.

Two federal statutes require the Secretary of Health and Human Services to issue standards of treatment for narcotic addiction. Section IV of Title I of the Comprehensive Drug Abuse Prevention and Control Act of 1970 directs the Secretary to "determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts." In addition, Section 3 of the Narcotic Addict Treatment Act (NATA) of 1974 required practitioners who dispensed methadone for maintenance or detoxification treatment to register each year with the Drug Enforcement Administration (DEA), which is instructed to register such applicants judged as qualified "under standards established by the Secretary" of Health and Human Services (originally Health, Education, and Welfare) to provide treatment services. Registrants are also required to comply with DEA's physical security and record-keeping requirements and with HHS's standards for "the quantities of narcotic drugs which may be provided for unsupervised use," namely, take-home medication.

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