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Drug compounding : background, issues and FDA oversight /
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 licen...
| Clasificación: | Libro Electrónico |
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| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
New York :
Nova Publishers,
[2014]
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| Colección: | Pharmacology-research, safety testing, and regulation series.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- 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.