【焦点】FDA正式效仿中医复方了吗

FDA网站对其新近提出的“Pharmacy Compounding”进行了详细“问答（Questions and Answers）”，主要包括：

What is “compounding”?

Is combining two or more drugs considered compounding?

Why do some patients need compounded drugs?

Are compounded drugs approved by the FDA?

Who regulates and inspects pharmacies that compound drugs?

What are the risks associated with compounded drugs?

Does FDA want to prevent traditional pharmacy compounding?

Questions and Answers Related to Specific Medications

看上去，是在“联合用药”的传统用药的含义上进行了适当的扩展，似乎开始效仿中医的“对症下药”的理念，允许医师根据单个病人的病症，采取多个药物联合用药，并调整药量或助剂，实现个体化医疗。但是，FDA并没有批准这样的“复方药物（compounded drugs）”，原文很清楚的描述了这一点：

Compounded drugs are not FDA-approved. This means that FDA does not verify the quality, safety and effectiveness of compounded drugs. This also means that compounded drugs lack an FDA finding of manufacturing quality. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective.

原文： http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm

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【wkh, 2013-06-03 22:35:08】 【责任人 wkh】 [已阅读 1002 次]