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Drug Quality and Security Act
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Drug Quality and Security Act : ウィキペディア英語版
Drug Quality and Security Act

The Drug Quality and Security Act () is a bill that would modify the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.〔 The bill was written in response to the New England Compounding Center meningitis outbreak that took place in 2012, which killed 64 people.〔 The bill was signed by President Obama on November 27, 2013.
==Background==
The bill was introduced by Rep. Upton in response to the New England Compounding Center meningitis outbreak that took place in 2012.〔 64 people were killed and 750 were infected by fungal meningitis.〔(【引用サイトリンク】url=http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html#casecount_table )〕 Rep. Upton's district had 3 deaths and there were 19 total in Michigan.〔
Compounding is the creation of a particular pharmaceutical product to fit the unique need of a patient. To do this, compounding pharmacists combine or process appropriate ingredients using various tools. This may be done for medically necessary reasons, such as to change the form of the medication from a solid tablet to a liquid, to avoid a non-essential ingredient that the patient is allergic to, or to obtain the exact dose(s) needed or deemed best of particular active pharmaceutical ingredient(s). It may also be done for more optional reasons, such as adding flavors to a medication or otherwise altering taste or texture.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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