After Heparin: - The Pew Charitable Trusts

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547 Cardinal Health, Inc. “Pharmaceutical RFID Report: Cardinal Health Releases RFID Pilot Results.” November 17, 2006. RFID Industry. http://www.rfid-industry.com/app/rx/pharmaceuticalsrfidsystems.htm. Accessed February 16, 2011. 548 UPS Supply Chain Solutions. “RFID in Healthcare—A Panacea for the Regulations and Issues Affecting the Industry?” White Paper. 2005. http://www.ups-scs.com/solutions/white_papers/wp_RFID_in_healthcare.pdf. Accessed February 16, 2011. 549 National Association of Boards of Pharmacy. Model Rules for the Licensure of Wholesale Distributors. Section 1. Requirements for Licensure and Section 2. Minimum Qualifications. Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy. August 2010. http://www.nabp.net/government-affairs/model-actrules/. Accessed October 14, 2010.
APPENDIX A Expert Interviews Bill Allmond, Vice President, Government Relations, Society of Chemical Manufacturers and Affiliates; Philippe Andre, MScPharm, MA, Director, Qualiau Pharmaceutical Auditing Co., Ltd., and Associate Professor at the School of Pharmaceutical Science and Technology, Tianjin University; Deborah M. Autor, Esq, Director, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration;* James Bao, PhD, Professor of Analytical Chemistry, Tianjin University; Nick Basta, Editor-in-Chief, Pharmaceutical Commerce; Prabir Basu, PhD, Executive Director, The National Institute for Pharmaceutical Technology and Education; Roger Bate, PhD, Legatum Fellow in Global Prosperity, American Enterprise Institute; Peter Beckerman, JD, Senior Policy Advisor, Office of Policy, U.S. Food and Drug Administration; Ilisa B.G. Bernstein, PharmD, JD, Director of Pharmacy Affairs, Office of Policy, Office of the Commissioner, U.S. Food and Drug Administration;* Arline Bilbo, Director, Member and Professional Relations, U.S. Pharmacopeial Convention; Carmen Catizone, M.S., RPh, DPh., Executive Director, National Association of Boards of Pharmacy; Robert Celeste, Director, GS1 Healthcare United States; James D. Coffey, Director, Massachusetts Board of Pharmacy; Marcia G. Crosse, Ph.D., Director, Health Care, U.S. Government Accountability Office; Diane Darvey, PharmD, JD, Director, Federal and State Public Policy, National Association of Chain Drug Stores; Benjamin England, Esq, Founder, Benjamin L. England & Associates, LLC, and FDAImports.com, LLC, former Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration; Adam J. Fein, PhD, Pembroke Consulting, Inc.; Ben Firschein, Director, Government Affairs, U.S. Pharmacopeial Convention; Elizabeth A. Gallenagh, Esq, Vice President, Government Affairs, Healthcare Distribution Management Association; Erin M. Gardiner, Director, Corporate Communications, Baxter International Inc.; Daniel H. Gold, PhD, President and CEO, D.H. Gold Associates, Inc.; James C. Griffiths, Vice President, Food, Dietary Supplement and Excipient Standards, U.S. Pharmacopeial Convention; Virginia Herold, MS, Executive Officer, California State Board of Pharmacy; Matthew Heyman, Vice President, External Affairs and Strategic Integration, U.S. Pharmacopeial Convention; David J. Horowitz, Assistant Commissioner for Policy, U.S. Food and Drug Administration; Jeanne Ireland, Assistant Commissioner for Legislation, Office of the Commissioner, U.S. Food and Drug Administration; Brenda Kelly, Vice President of Marketing, SupplyScape; Robert Kennedy, Manager of Industry Research, Healthcare & Science, Thomson Reuters; David A. Kessler, MD, Professor of Pediatrics and Epidemiology and Biostatistics at the School of Medicine, University of California, San Francisco, Former Commissioner, * Title at time of interview After Heparin: PRotecting Consumers from the Risks of Substandard and Counterfeit Drugs 105
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After Heparin: Protecting Consumers
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TABLE OF CONTENTS 1.4 Problems with
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Executive Summary In late 2007, U.S
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Executive Summary eventually being
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Introduction and Background U.S. ph
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INTRODUCTION AND BACKGROUND less ri
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50 0 INTRODUCTION AND BACKGROUND un
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INTRODUCTION AND BACKGROUND in Chin
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CHAPTER1 PHARMACEUTICAL MANUFACTURI
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PHARMACEUTICAL MANUFACTURING: GLOBA
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500000000 0 —Chapter 2— Figure
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—Chapter 2— FDA inspected only
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Page 55 and 56: —Chapter 2— 3. Allow the FDA to
Page 57 and 58: CHAPTER3 PHARMACEUTICAL DISTRIBUTIO
Page 59 and 60: PHARMACEUTICAL DISTRIBUTION As dist
Page 61 and 62: PHARMACEUTICAL DISTRIBUTION Case st
Page 63 and 64: PHARMACEUTICAL DISTRIBUTION Sidebar
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Page 67 and 68: PHARMACEUTICAL DISTRIBUTION the age
Page 69 and 70: PHARMACEUTICAL DISTRIBUTION 3.4 Pew
Page 71 and 72: PHARMACEUTICAL DISTRIBUTION d. If t
Page 73 and 74: REFERENCES 16 Fagan, Kevin. Testimo
Page 75 and 76: REFERENCES 58 Schwartzkopff, France
Page 77 and 78: REFERENCES 111 NSD Bio Group. “Po
Page 79 and 80: REFERENCES 155 State Food and Drug
Page 81 and 82: REFERENCES 195 U.S. Food and Drug A
Page 87 and 88: REFERENCES 332 Public Law 111-8—M
Page 89 and 90: REFERENCES 378 Villax, Guy. Board M
Page 91 and 92: REFERENCES 429 U.S. Supreme Court,
Page 93 and 94: REFERENCES 479 Michelle M. Ciolek,
Page 95: REFERENCES 521 21 USC §828 (a). 52
Page 99 and 100: APPENDIX B Pew Stakeholder Conferen
Page 101 and 102: APPENDIX C Pew Stakeholder Conferen
Page 103 and 104: Pew Stakeholder Conference Agenda T
Page 105 and 106: acknowledgments We gratefully ackno
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