Drug Compounding Pharmacies: Risks and Oversight Issues

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Seth Sharpe (Editor)

Series: Pharmacology – Research, Safety Testing and Regulation, Public Health in the 21st Century
BISAC: MED071000

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. (Imprint: Nova)

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Table of Contents

Preface

Federal Authority to Regulate the Compounding of Human Drugs
(Andrew Nolan, CRS)

FDA’s Authority to Regulate Drug Compounding: A Legal Analysis
(Jennifer Staman, CRS)

State of Disarray: How States’ Inability to Oversee Compounding Pharmacies Puts Public Health at Risk
(The staff of the Office of Congressman Edward J. Markey)

Compounding Pharmacies, Compounding Risk
(The staff of the Office of Congressman Edward J. Markey)

The New England Compounding Center and the Meningitis Outbreak of 2012: A Failure to Address Risk to the Public Health
(Staff Report of the Senate Health, Education, Labor, and Pensions Committee)

Selected Resources on Federal Oversight of Compounding Pharmacies
(Judith M. Glassgold, Susan Thaul, Janet Kinzer, CRS)

Index

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