dbo:abstract
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- The Drug Quality and Security Act (H.R. 3204) is a law that amended 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. Title I of the DQSA comprises the Compounding Quality Act (CQA), which amends regulations concerning compounding drugs. Title II, the Drug Supply Chain Security Act (DSCSA), established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. These requirements included a ten-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States." (en)
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- 24441 (xsd:nonNegativeInteger)
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dbp:actsAffected
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- Federal Food, Drug, and Cosmetic Act, Public Health Service Act, Comprehensive Drug Abuse Prevention and Control Act of 1970, Atomic Energy Act of 1954, and others. (en)
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dbp:agenciesaffected
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dbp:authorizationsofappropriations
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- an unlimited amount in fiscal 2014 to be spent at any time (en)
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- To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. (en)
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- Drug Quality and Security Act (en)
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- 2013-09-28 (xsd:date)
- 2013-11-18 (xsd:date)
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- , , , , , and others. (en)
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rdfs:comment
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- The Drug Quality and Security Act (H.R. 3204) is a law that amended 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. (en)
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- Drug Quality and Security Act (en)
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