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

Bram, Martti, (editor.).
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Electronic resources

Subject: United States. Food and Drug Administration.
Drugs > Dosage forms > United States > Evaluation.
Pharmaceutical industry > United States > Quality control.
Public health > Standards > United States.
Products liability > Drugs > United States.
Genre: Electronic books.

Record details

  • ISBN: 9781631173615
  • ISBN: 1631173618
  • Physical Description: 1 online resource (155 pages) : map.
  • Publisher: New York : Nova Publishers, [2014]

Content descriptions

Bibliography, etc. Note: Includes bibliographical references and index.
Formatted Contents Note: 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.
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.
Source of Description Note: Online resource; title from PDF title page (ebrary, viewed February 27, 2014).

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