Fed Regist. 1983 Sep 13;48(178):41049-51.
The Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) are requesting comments on: (1) Whether to make the methadone regulations concerning narcotic addiction more flexible to accommodate more readily changes in medical practice while at the same time providing quality care and protecting against illicit diversion; and (2) whether to revise or eliminate the recordkeeping, reporting, and other requirements that may be unnecessary and/or overly burdensome as a result of changes in the state-of-the-art. The agencies will use information received in comments to determine appropriate changes to the methadone regulations. This action is the result of a retrospective review of the methadone regulations as required by law and by directive of the Office of Management and Budget.
美国食品药品监督管理局(FDA)和美国国家药物滥用研究所(NIDA)正在就以下事项征求意见:(1)是否使有关麻醉品成瘾的美沙酮法规更加灵活,以便更轻松地适应医疗实践中的变化,同时提供高质量护理并防止非法转移;(2)是否修订或取消由于技术发展而可能不必要和/或负担过重的记录保存、报告及其他要求。这些机构将利用收到的意见中的信息来确定对美沙酮法规的适当修改。此行动是根据法律要求以及管理和预算办公室的指示对美沙酮法规进行回顾性审查的结果。