Federal Regulation of Clinical Practice in Narcotic Addiction Treatment: Purpose, Status, and Alternatives

Abstract

The regulation of narcotic medications used in narcotic addiction treatment is unique in medical therapeutics. Physicians who want to use narcotics for this indication must obtain a separate annual registration from the Drug Enforcement Administration (DEA). Annual registration is contingent on compliance with both the DEA's security regulations (inventory, record-keeping, and physical security) as well as treatment regulations jointly promulgated by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA).During the last decade, a number of events have occurred that persuaded NIDA that it is time to reevaluate the current method by which the Department of Health and Human Services (HHS) regulates methadone treatment. As a result of research during the past twenty years, we have learned about the effective components of methadone treatment. In comparison to other available treatment modalities for opioid addiction, methadone treatment is uniquely effective when administered by well-trained medical staffs.