Drug compounding pharmacies : risk and oversight issues / Seth Sharpe, editor.

Format:

Book

Contributor:

Sharpe, Seth, editor.

Series:

Public health in the 21st century series.

Pharmacology, research, safety testing and regulation

Public health in the 21st century

Language:

English

Subjects (All):

United States. Food and Drug Administration.

United States.

United States. Federal Food, Drug, and Cosmetic Act.

Pharmaceutical technology--Standards.

Pharmaceutical technology.

Pharmaceutical industry--United States--Quality control.

Pharmaceutical industry.

Products liability--Drugs--United States.

Products liability.

Physical Description:

1 online resource (184 pages)

Place of Publication:

[Hauppauge] New York : Nova Publishers, [2013]

Summary:

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.

Notes:

Includes bibliographical references and index.

Description based on print version record.

ISBN:

1-62808-177-5