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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。

相似文献

1
Registration requirements for importers and manufacturers of prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine. Final rule.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。
Fed Regist. 2010 Feb 1;75(20):4973-82.
2
Implementation of the Comprehensive Methamphetamine Control Act of 1996; regulation of pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products and reports of certain transactions to nonregulated persons. Final rule.1996年《甲基苯丙胺综合管制法》的实施；对伪麻黄碱、苯丙醇胺及麻黄碱复方药品的管制以及向非受管制人员报告某些交易。最终规则。
Fed Regist. 2002 Mar 28;67(60):14853-62.
3
Removal of thresholds for the List I chemicals pseudoephedrine and phenylpropanolamine. Final rule.取消附表I化学品伪麻黄碱和苯丙醇胺的管制阈值。最终规则。
Fed Regist. 2010 Jul 7;75(129):38915-22.
4
Import and production quotas for certain List I chemicals. Interim final rule with request for comment.某些第一类化学品的进口和生产配额。征求意见的暂行最终规则。
Fed Regist. 2007 Jul 10;72(131):37439-53.
5
Information on foreign chain of distribution for ephedrine, pseudoephedrine, and phenylpropanolamine. Final rule.关于麻黄碱、伪麻黄碱和苯丙醇胺的国外分销链信息。最终规则。
Fed Regist. 2010 Mar 5;75(43):10168-72.
6
Retail sales of scheduled listed chemical products; self-certification of regulated sellers of scheduled listed chemical products. Interim final rule with request for comment.列入清单的化学产品的零售销售；列入清单的化学产品受监管销售商的自我认证。带有征求意见的暂行最终规则。
Fed Regist. 2006 Sep 26;71(186):56008-27.
7
Exemption of chemical mixtures containing the List I chemicals ephedrine, N-methylephedrine, N-methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and pseudoephedrine. Final rule.含有第一类化学品麻黄碱、N-甲基麻黄碱、N-甲基伪麻黄碱、去甲伪麻黄碱、苯丙醇胺和伪麻黄碱的化学混合物的豁免。最终规则。
Fed Regist. 2003 May 1;68(84):23195-206.
8
Elimination of exemptions for chemical mixtures containing the list I chemicals ephedrine and/or pseudoephedrine. Final rule.取消含有附表一化学品麻黄碱和/或伪麻黄碱的化学混合物的豁免规定。最终规则。
Fed Regist. 2008 Jul 10;73(133):39611-4.
9
Implementation of the Methamphetamine Anti-Proliferation Act; thresholds for retailers and for distributors required to submit mail order reports; changes to mail order reporting requirements. Final rule.《甲基苯丙胺反扩散法案》的实施；零售商及需提交邮购报告的经销商的阈值；邮购报告要求的变更。最终规则。
Fed Regist. 2003 Oct 7;68(194):57799-804.
10
Self-certification and employee training of mail-order distributors of scheduled listed chemical products. Interim final rule with request for comment.列管化学产品邮购经销商的自我认证及员工培训。征求意见的暂行最终规则。
Fed Regist. 2011 Apr 13;76(71):20518-24.

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Ephedrine for myasthenia gravis, neonatal myasthenia and the congenital myasthenic syndromes.用于重症肌无力、新生儿肌无力及先天性肌无力综合征的麻黄碱。
Cochrane Database Syst Rev. 2014 Dec 17;2014(12):CD010028. doi: 10.1002/14651858.CD010028.pub2.