Drug Compounding: Background, Issues and FDA Oversight


Martti Bram (Editor)

Series: Pharmacology – Research, Safety Testing and Regulation
BISAC: MED071000

Compounding has been traditionally defined as a process where a pharmacist or a physician combines, mixes or alters ingredients to create a medication tailored to the needs of an individual patient. Traditionally compounded drugs (CDs) are made in response to an individual prescription from a licensed health provider in the context of a pharmacists and health care professionals relationship with a specific patient.

This book provides background information on CDs and non-traditional compounding pharmacies relevant to policy discussions. This book will also examine the FDA’s regulation of drug compounding and will discuss relevant legal authorities. Specifically, the status of FDA’s authority to oversee drug compounding, and the gaps, if any, between state and federal authority will be discussed, as well as how FDA has used its data and authority to oversee drug compounding and the actions taken or planned by states or national pharmacy organizations to improve oversight of drug compounding. (Imprint: Nova)

Table of Contents

Table of Contents


Chapter 1. Compounded Drugs
Judith M. Glassgold

Chapter 2. Federal Authority to Regulate the Compounding of Human Drugs
Andrew Nolan

Chapter 3. Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight
United States Government Accountability Office

Chapter 4. Statement of Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration. Hearing on ”Examining Drug Compounding”

Chapter 5. Testimony of Scott Gottlieb, Resident Fellow, The American Enterprise Institute. Hearing on ”Examining Drug Compounding”

Chapter 6. Testimony of Joe Harminson, Owner of DFW Prescriptions, on Behalf of the National Community Pharmacists Association. Hearing on ”Examining Drug Compounding”


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