unlike any other prescription drug and any other controlled substance, methadone—when used to treat opiate addiction—has also been subjected to a third layer of federal regulations. These regulations govern in great detail how physicians may—and may not—care for opiate-dependent patients and are enforced by federal agents.

The special methadone regulations flow from two statutory requirements that the Secretary of HHS (formerly the Secretary of Health, Education, and Welfare) issue standards of treatment for narcotic addiction. Section IV of Title I of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law 91-513) charged the Secretary to "determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts."

Section 3 of the Narcotic Addict Treatment Act of 1974 (Public Law 93-281) reiterated this authority and expanded the charge. It required practitioners who dispensed narcotic drugs to individuals for maintenance or detoxification treatment to obtain an annual registration from DEA. DEA was directed to register such applicants if, among other things, they were determined by the Secretary of HHS to be qualified "under standards established by the Secretary" to engage in the treatment activity.

Registration also required a determination by DEA that the applicant would comply with DEA's physical security and record-keeping requirements and with HHS's standards, developed in consultation with DEA, regarding "the quantities of narcotic drugs which may be provided for unsupervised use by individuals in such treatment." "Unsupervised use" refers to take-home medication.

The focus of all these laws and regulations is a pharmaceutical agent. Methadone hydrochloride (6-dimethylamino-4, 4-diphenyl-3-heptanone hydrochloride) is a synthetic opiate developed in Germany during World War II as an alternative to morphine. It was approved by FDA in 1947 as a medication for analgesic and antitussive (relieving or preventing cough) uses.

In the mid-1960s, methadone was shown to be effective in the treatment of opiate addiction and thereafter became widely available for this use. Today, an estimated 115,000 individuals receive methadone treatment for opiate addiction, and many thousands more have received it over the past two decades.

There are two basic types of methadone treatment—detoxification therapy and maintenance therapy. Detoxification therapy involves the use of methadone to reduce the symptoms of acute abstinence (or withdrawal) following cessation of opiate use. Methadone maintenance therapy involves the use of methadone on a sustained basis to reduce or eliminate compulsive opiate use by substituting a drug that produces long-lasting activation of opioid receptors in the brain without causing uncontrolled craving effects or interfering with



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