| Description |
1 online resource (155 pages) : map |
| Series |
Pharmacology-research, safety testing and regulation |
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Pharmacology-research, safety testing, and regulation series.
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| 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 |
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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 |
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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 |
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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 |
| 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 |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Online resource; title from PDF title page (ebrary, viewed February 27, 2014) |
| Subject |
United States. Food and Drug Administration.
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| SUBJECT |
United States. Food and Drug Administration fast |
| Subject |
Drugs -- Dosage forms -- United States -- Evaluation
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Pharmaceutical industry -- United States -- Quality control
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Public health -- Standards -- United States
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Products liability -- Drugs -- United States
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MEDICAL -- Pharmacology.
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Pharmaceutical industry -- Quality control
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Products liability -- Drugs
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Public health -- Standards
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United States
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| Form |
Electronic book
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| Author |
Bram, Martti, editor
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| ISBN |
9781631173615 |
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1631173618 |
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