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History of Methadone Regulation Federal Regulation  


History of Methadone Regulation Federal regulation In 1972, FDA issued regulations governing eligibility, evaluation procedures, dosages, take-home medications, frequency of patient visits, medical and psychiatric services, counseling, support services, and related details for methadone treatment programs. Several modifications were made to these regulations during the 1980s. Until 2001, FDA was responsible for approving these programs and ensuring compliance with FDA regulations.

As experience with the effectiveness of methadone grew, criticism of the 1972 FDA regulations increased from physicians, who complained that the regulations placed burdens on their practice of medicine, and from addiction treatment specialists, who pointed out that proscriptive regulations failed to leave room for treatment innovation. (See comments on the new rules in their proposed form [Federal Register 64:39812–39814].)

The movement away from a compliance orientation and toward an accreditation model was supported by a number of reviews, including the 1997 NIH consensus development conference on Effective Treatment of Opiate Addiction and the review of 1972 FDA regulations by IOM (Institute of Medicine 1995). Interest in accreditation grew because of its emphasis on self-assessment and improvement and on integration of quality assurance and performance elements developed by expert accreditation organizations. In addition, trends in national health care fueled movement toward accreditation. Many managed care organizations require all accredited health care practitioners to demonstrate quality care. Several States grant exemptions from State licensing requirements (called “deemed status”) to accredited health care facilities.

Final regulations issued by DHHS and the Substance Abuse and Mental Health Services Administration (SAMHSA) on January 17, 2001, effective May 18, 2001, govern the use of methadone and LAAM in both maintenance and detoxification treatments for opioid addiction. The 1972 FDA regulations were repealed, and a new accreditation-based regulatory system was created. The new system shifted administration and oversight from FDA to SAMHSA. The new regulations acknowledged that addiction is a medical disorder not amenable to one-size-fits-all treatment. They recognized that different patients, at different times, could need vastly different services.

Accreditation itself is a peer-review process that evaluates a treatment program against SAMHSA's opioid treatment standards and accreditation standards of SAMHSA-approved accrediting bodies (42 Code of Federal Regulations, Part 8). It includes site visits by specialists with experience in opioid pharmacotherapy and related activities.

The new regulations establish an entirely different regulatory and oversight structure for MAT. The DEA role remains the same, but FDA's authority to approve and monitor programs has been transferred to SAMHSA. Instead of detailed proscriptive rules, the new regulations set forth general certification requirements and Federal opioid treatment standards. These are elaborated in best-practice guidelines and in accreditation “elements” (or standards) developed by the SAMHSA-approved accreditation bodies. SAMHSA has employed a series of expert panels to develop guidelines for an accreditation-based certification system. Placing detailed practice criteria in accreditation standards rather than in regulations permits SAMHSA and the accreditation bodies to update the standards as needed.

The new regulations provide that, once a program is accredited, SAMHSA uses accreditation results along with other data to determine whether the program is qualified to carry out treatment under the standards in the regulations. SAMHSA maintains oversight of accreditation elements in its review of accreditation bodies' initial and renewal applications.

The consensus panel for this TIP expects the accreditation process to result in an integrated and individualized approach to services, increased patient satisfaction, better staff recruitment, enhanced community confidence and outcomes, and improvements in quality of care. The shift to accreditation enables SAMHSA to focus its oversight efforts on improving treatment rather than ensuring that programs are meeting regulatory criteria.