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Drug Compounding Pharmacies Hardback - 2013

by Seth Sharpe

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In light of the 2012 fungal meningitis outbreak, believed to have been caused by a contaminated compounded steroid injection, the regulation of human drug compounding has received significant attention. Drug compounding in its traditional form is the process of combining, mixing, or altering ingredients in order to create a medication for a particular patient. However, as illustrated by the entity that created the steroid medication linked with the meningitis outbreak, concerns have been raised about compounding pharmacies producing drugs on a larger scale. While drug compounding has historically been the focus of state governments through their regulation of pharmacies, questions have arisen regarding the extent the federal government can regulate the practice of compounding through the Food, Drug, and Cosmetic Act (FDCA). This book examines the FDA's regulation of drug compounding and discusses relevant legal authorities, and the potential limits to the FDA's authority to regulate human drug compounding.

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  • Title Drug Compounding Pharmacies
  • Author Seth Sharpe
  • Binding Hardback
  • Pages 137
  • Volumes 1
  • Language ENG
  • Publisher Nova Science Publishers
  • Publication date 2013
  • ISBN 9781628081763 / 1628081767
  • Category Business / Economics / Finance
  • Library of Congress subjects United States, Products liability - Drugs - United States
  • Library of Congress Catalogue Number 2013443433
  • Dewey Decimal Code 338.476

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Drug Compounding Pharmacies: Risks and Oversight Issues (Pharmacology-Research, Safety Testing and Regulation)

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Drug Compounding Pharmacies: Risks & Oversight Issues

Drug Compounding Pharmacies: Risks & Oversight Issues

by Seth Sharpe

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Drug Compounding Pharmacies: Risks and Oversight Issues

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Drug Compounding Pharmacies: Risks and Oversight Issues (Pharmacology-Research, Safety Testing and Regulation)

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Drug Compounding Pharmacies: Risks and Oversight Issues (Pharmacology-Research, Safety Testing and Regulation)

by Seth Sharpe ,

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