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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 |
|---|---|
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
New York :
Nova Publishers,
[2014]
|
| Colección: | Pharmacology-research, safety testing, and regulation series.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 245 | 0 | 0 | |a Drug compounding : |b background, issues and FDA oversight / |c Martti Bram, editor. |
| 264 | 1 | |a New York : |b Nova Publishers, |c [2014] | |
| 264 | 4 | |c ©2014 | |
| 300 | |a 1 online resource (155 pages) : |b map | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 490 | 1 | |a Pharmacology-research, safety testing and regulation | |
| 504 | |a Includes bibliographical references and index. | ||
| 588 | 0 | |a Online resource; title from PDF title page (ebrary, viewed February 27, 2014). | |
| 520 | |a 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. | ||
| 505 | 0 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 590 | |a eBooks on EBSCOhost |b EBSCO eBook Subscription Academic Collection - Worldwide | ||
| 610 | 1 | 0 | |a United States. |b Food and Drug Administration. |
| 610 | 1 | 7 | |a United States. |b Food and Drug Administration. |2 fast |0 (OCoLC)fst00549734 |
| 650 | 0 | |a Drugs |x Dosage forms |z United States |x Evaluation. | |
| 650 | 0 | |a Pharmaceutical industry |z United States |x Quality control. | |
| 650 | 0 | |a Public health |x Standards |z United States. | |
| 650 | 0 | |a Products liability |x Drugs |z United States. | |
| 650 | 6 | |a Médicaments |x Formes pharmaceutiques |z États-Unis |x Évaluation. | |
| 650 | 6 | |a Industrie pharmaceutique |z États-Unis |x Qualité |x Contrôle. | |
| 650 | 6 | |a Santé publique |x Normes |z États-Unis. | |
| 650 | 6 | |a Responsabilité du fait des produits |x Médicaments |z États-Unis. | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
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| 650 | 7 | |a Products liability |x Drugs. |2 fast |0 (OCoLC)fst01078391 | |
| 650 | 7 | |a Public health |x Standards. |2 fast |0 (OCoLC)fst01082312 | |
| 651 | 7 | |a United States. |2 fast |0 (OCoLC)fst01204155 | |
| 700 | 1 | |a Bram, Martti, |e editor. | |
| 776 | 0 | 8 | |i Print version: |a Bram, Martti. |t Drug Compounding : Background, Issues and FDA Oversight. |d Hauppauge : Nova Science Publishers, Inc., ©1900 |z 9781631173608 |
| 830 | 0 | |a Pharmacology-research, safety testing, and regulation series. | |
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