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Title Drug compounding : background, issues and FDA oversight / Martti Bram, editor.

Publication Info. New York : Nova Publishers, [2014]
©2014

Item Status

Description 1 online resource (155 pages) : map.
Physical Medium polychrome
Description text file
Series Pharmacology-research, safety testing and regulation
Pharmacology-research, safety testing, and regulation series.
Bibliography Includes bibliographical references and index.
Summary 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 pharmacist's and health care professional's 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 dr.
Contents DRUG COMPOUNDING: BACKGROUND, ISSUES AND FDA OVERSIGHT; DRUG COMPOUNDING: BACKGROUND, ISSUES AND FDA OVERSIGHT; Library of Congress Cataloging-in-Publication Dat; CONTENTS; PREFACE; Chapter 1: COMPOUNDED DRUGS; SUMMARY; INTRODUCTION; BACKGROUND; EXISTING REGULATORY OVERSIGHT; GROWTH OF NON-TRADITIONAL COMPOUNDING; ISSUES FOR CONSIDERATION; APPENDIX A. LEGISLATION INTRODUCED IN THE 113TH CONGRESS AFFECTING DRUG COMPOUNDING; APPENDIX B. CONGRESSIONAL HEARINGS ON CDS 2012-2013 (IN REVERSE CHRONOLOGICAL ORDER); APPENDIX C. SELECTED ADVERSE EVENTS INVOLVING COMPOUNDED DRUGS AND SOLUTIONS.
Chapter 2: FEDERAL AUTHORITY TO REGULATETHE COMPOUNDING OF HUMAN DRUGSSUMMARY; BACKGROUND; FEDERAL REGULATION OF COMPOUNDED DRUGS; LIMITS ON FEDERAL AUTHORITY TO REGULATE COMPOUNDED DRUGS; Chapter 3: DRUG COMPOUNDING: CLEAR AUTHORITY AND MORE RELIABLE DATA NEEDED TO STRENGTHEN FDA OVERSIGHT; WHY GAO DID THIS STUDY; WHAT GAO RECOMMENDS; WHAT GAO FOUND; ABBREVIATIONS; BACKGROUND; UNCLEAR FEDERAL AUTHORITY AND LACK OF CONSENSUS ON WHEN DRUG COMPOUNDING BECOMES MANUFACTURING; FDA LACKS RELIABLE AND TIMELY DATA ON COMPOUNDING PHARMACIES, BUT HAS FOUND PROBLEMS THROUGH ITS LIMITED OVERSIGHT.
STATES AND NATIONAL ORGANIZATIONS HAVE TAKEN VARIOUS ACTIONS TO STRENGTHEN OVERSIGHT OF DRUG COMPOUNDINGCONCLUSION; MATTER FOR CONGRESSIONAL CONSIDERATION; RECOMMENDATIONS FOR EXECUTIVE ACTION; AGENCY COMMENTS AND OUR EVALUATION; APPENDIX I: INFORMATION ON SELECTION CRITERIA FOR FOUR STATES; APPENDIX II: HISTORY OF THE FOOD AND DRUG ADMINISTRATION'S (FDA) AUTHORITY OVER DRUG COMPOUNDING AND APPROACH TO OVERSIGHT; Chapter 4: STATEMENT OF JANET WOODCOCK, DIRECTOR, CENTER FOR DRUG EVALUATION AND RESEARCH, FOODAND DRUG ADMINISTRATION. HEARINGON ''EXAMINING DRUG COMPOUNDING''; INTRODUCTION.
CONCLUSIONChapter 5: TESTIMONY OF SCOTT GOTTLIEB, RESIDENT FELLOW, THE AMERICAN ENTERPRISE INSTITUTE. HEARINGON ''EXAMINING DRUG COMPOUNDING''; KEY POINTS; INTRODUCTION; CONCLUSION; Chapter 6: TESTIMONY OF JOE HARMINSON, OWNER OF DFW PRESCRIPTIONS, ON BEHALFOF THE NATIONAL COMMUNITY PHARMACISTS ASSOCIATION. HEARINGON ''EXAMINING DRUG COMPOUNDING''; INDEX.
Local Note eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America
Subject United States. Food and Drug Administration.
United States. Food and Drug Administration.
Drugs -- Dosage forms -- United States -- Evaluation.
Drugs -- Dosage forms.
United States.
Evaluation.
Pharmaceutical industry -- United States -- Quality control.
Pharmaceutical industry.
Quality control.
Public health -- Standards -- United States.
Public health -- Standards.
Public health.
Products liability -- Drugs -- United States.
Products liability -- Drugs.
Genre/Form Electronic books.
Subject Medication.
Added Author Bram, Martti, editor.
Other Form: Print version: Bram, Martti. Drug Compounding : Background, Issues and FDA Oversight. Hauppauge : Nova Science Publishers, Inc., ©1900 9781631173608
ISBN 9781631173615 (electronic book)
1631173618 (electronic book)
9781631173608