Drug Compounding Pharmacies: Risks & Oversight Issues by Seth Sharpe (English) H

Drug Compounding Pharmacies

by Seth Sharpe

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.

FORMAT Hardcover LANGUAGE English CONDITION Brand New

Table of Contents

Preface; Federal Authority to Regulate the Compounding of Human Drugs; FDAs Authority to Regulate Drug Compounding: A Legal Analysis; State of Disarray: How States' Inability to Oversee Compounding Pharmacies Puts Public Health at Risk; Compounding Pharmacies, Compounding Risk; The New England Compounding Center & the Meningitis Outbreak of 2012: A Failure to Address Risk to the Public Health; Selected Resources on Federal Oversight of Compounding Pharmacies; Index.

Details ISBN1628081767 Author Seth Sharpe Pages 137 Publisher Nova Science Publishers Inc ISBN-10 1628081767 ISBN-13 9781628081763 Format Hardcover Imprint Nova Science Publishers Inc Place of Publication New York Country of Publication United States Year 2013 Publication Date 2013-09-01 DEWEY 338.476151 Subtitle Risks & Oversight Issues Short Title Drug Compounding Pharmacies Language English UK Release Date 2013-09-01 AU Release Date 2013-09-01 NZ Release Date 2013-09-01 US Release Date 2013-09-01 Audience Professional & Vocational

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TheNile_Item_ID:76648230;

• Condition: Brand New
• Format: Hardcover
• Language: English
• ISBN-13: 9781628081763
• Author: Seth Sharpe
• Book Title: Drug Compounding Pharmacies

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