§ 310.304 - Drugs that are subjects of approved new drug applications and that require special studies, records, and reports.

Listed below are the new drugs and requirements referred to in § 310.303:

(a) [Reserved]

(b) Methadone. Methadone may be used as an analgesic in severe pain, for the detoxification of narcotic addicts, and as an oral substitute for heroin or other morphine-like drugs, in the maintenance treatment of narcotic addicts, pursuant to the conditions established in § 291.505. Further data and information are required to establish the safety and effectiveness of methadone under a variety of conditions during widespread and long-term use. In view of the tremendous public health and social problems associated with the use of heroin, the demonstrated usefulness of methadone in treatment, the lack of a safe and effective alternative drug or treatment modality, the need for additional safety and effectiveness data on methadone for narcotic addict treatment and the danger to health that could be created by uncontrolled distribution and use of methadone for narcotic addict treatment, the Commissioner of Food and Drugs finds that it is not in the public interest either to withhold the drug from the market until it has been proved safe and effective under all conditions of use for narcotic addict treatment or to grant full approval for unrestricted distribution, prescription, dispensing, or administration of methadone for this use. The Commissioner therefore concludes that it is essential to the public interest to prescribe detailed conditions for safe and effective use of methadone for narcotic addict treatment, utilizing the IND and NDA control mechanisms and the authority granted under the Comprehensive Drug Abuse Prevention and Control Act of 1970, to assure that the required additional information for assessing the safety and effectiveness of methadone is obtained, to maintain close control over the safe distribution, administration, and dispensing of the drug, and to detail responsibilities for such control. The conditions established in § 291.505 constitute a determination of the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts with respect to the use of methadone, pursuant to section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970.