含麻黄碱、伪麻黄碱或苯丙醇胺的处方药产品进口商和制造商的注册要求。最终规则。
Registration requirements for importers and manufacturers of prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine. Final rule.
出版信息
Fed Regist. 2010 Feb 1;75(20):4973-82.
PMID:20352663
Abstract
The Drug Enforcement Administration (DEA) is amending its registration regulations to ensure that a registration is obtained for every location where ephedrine, pseudoephedrine, or phenylpropanolamine, or drug products containing one of these chemicals, are imported or manufactured. These amendments will make it possible to establish the system of quotas and assessment of annual needs for the importation and manufacture of these chemicals that Congress mandated in the Combat Methamphetamine Epidemic Act of 2005.
摘要
美国药品管理局（DEA）正在修订其注册规定，以确保对麻黄碱、伪麻黄碱、苯丙醇胺或含有这些化学物质之一的药品进行进口或生产的每个地点都获得注册。这些修订将使建立国会在2005年《打击甲基苯丙胺流行法案》中规定的这些化学品进口和生产配额及年度需求评估系统成为可能。
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