The drug package that a community pharmacist hands to a patient, or a hospital pharmacist sends to a patient's bedside, or a physician administers in the medical office has reached the end of a complicated path. That path is called a supply or distribution chain. The upstream portion of the chain includes the journey of each active and inactive ingredient and their chemical components to the manufacturer that creates the finished drug product. The downstream chain, which this report addresses, includes the repackagers, wholesale distributors, associated storage and transport companies, and, finally, the dispenser.
Dispensers include independent community or chain pharmacies, hospitals or other health care facilities, and physicians' offices. Usually the supply chain provides consumers with unadulterated prescription drugs. However, the chain is potentially vulnerable, and when it breaks, a dispenser might provide a counterfeit product containing no active ingredient, less-than-labeled dosage, or a dangerous substitution. The dispenser might also provide a mishandled or diverted drug that has become sub- or superpotent or has gone past its expiration Usually the supply chain provides consumers with unadulterated prescription drugs.
However, the chain is potentially vulnerable, and when it breaks, a dispenser might provide a counterfeit product containing no active ingredient, less-than-labeled dosage, or a dangerous substitution. The dispenser might also provide a mishandled or diverted drug that has become sub- or superpotent or has gone past its expiration. This book serves as a primer on pharmaceutical supply chain issues. It describes the chain from manufacturer to patient, including where it is vulnerable; summarizes current federal law, regulation, and FDA policies that Congress and the agency designed to protect theintegrity of the final drag product, and indicates where those protections may falter; notes state-level and professional association activities; and discusses areas that Congress, FDA, and industry, health care, and patient stakeholders have suggested might be changed to increase the security of the pharmaceutical supply chain.
Chapter 1 - This report serves as a primer on pharmaceutical supply chain issues. It (1) describes the chain from manufacturer to patient, including where it is vulnerable; (2) summarizes current federal law, regulation, and FDA policies that Congress and the agency designed to protect the integrity of the final drag product, and indicates where those protections may falter; (3) notes state-level and professional association activities; and (4) discusses areas that Congress, FDA, and industry, health care, and patient stakeholders have suggested might be changed to increase the security of the pharmaceutical supply chain.
Chapter 2 - This is the Statement of Janet Woodcock, Director, Center for Drag Evaluation and Research, FDA.
Chapter 3 - This is the Testimony of Elizabeth A. Gallenagh, Vice President, Government Affairs, Healthcare Distribution Management Association.
Chapter 4 - This is the Testimony of Christine Simmon, Senior Vice President, Policy & Strategic Alliances, Generic Pharmaceutical Association.
Chapter 5 - This is the Testimony of Michael Rose, Vice President, Supply Chain Visibility, Johnson and Johnson Health Care Systems, Inc.
Chapter 6 - This is the Testimony of Tim Davis, Owner, Beaver Health Mart Pharmacy.
Chapter 7 - This is the Testimony of Allan Coukell, Director, Medical Programs, The Pew Charitable Trusts.
Chapter 8 - This is the Testimony of Carmen A. Catizone, Executive Director, National Association of Boards of Pharmacy.
Chapter 9 - This is the Statement of Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA.
Chapter 10 - This is the Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain. Statement of Marcia Crosse, Director, Health Care, U.S. Government Accountability Office.

Preface vii

Chapter 1 Pharmaceutical Supply Chain Security 1 Susan Thaul

Chapter 2 Statement of Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA. Hearing on "Securing Our Nation's Prescription Drug Supply Chain" 27

Chapter 3 Testimony of Elizabeth A. Gallenagh, Vice President, Government Affairs, Healthcare Distribution Management Association. Hearing on "Securing Our Nation's Prescription Drug Supply Chain" 33

Chapter 4 Testimony of Christine Simmon,Senior Vice President, Policy & Strategic Alliances, Generic Pharmaceutical Association. Hearing on "Securing Our Nation's Prescription Drug Supply Chain" 37

Chapter 5 Testimony of Michael Rose, Vice President, Supply Chain Visibility, Johnson and Johnson Health Care Systems, Inc. Hearing on "Securing Our Nation's Prescription Drug Supply Chain" 45

Chapter 6 Testimony of Tim Davis, Owner, Beaver Health Mart Pharmacy. Hearing on "Securing Our Nation's Prescription Drug Supply Chain" 49

Chapter 7 Testimony of Allan Coukell, Director, Medical Programs, The Pew Charitable Trusts. Hearing on "Securing Our Nation's Prescription Drug Supply Chain" 53

Chapter 8 Testimony of Carmen A. Catizone, Executive Director, National Association of Boards of Pharmacy. Hearing on "Securing Our Nation's Prescription Drug Supply Chain" 61

Chapter 9 Statement of Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA. Hearing on "Securing The Pharmaceutical Supply Chain" 67

Chapter 10 Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain. Statement of Marcia Crosse, Director, Health Care, U.S. Government Accountability Office. Hearing on "Securing the Pharmaceutical Supply Chain" 77

Index 93

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