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Supply Chain Construction

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Table of Contents

Introduction: The Good, the Bad, the Ugly, and the Necessary Who Gives It a Second Thought? The Pharma Industry: The Good-Positive Impact on Human Life The Pharma Industry: The Bad-Negative Impact on Human Life Recalls-A Way of Life The Pharma Industry: The Ugly-Human Life Lost The Pharma Industry: The Necessary-The Drug Quality and Security Act (H.R. 3204) The Book Chapters Endnotes H.R. 3204: The Journey and Expected Destination How Did We Get to November 27, 2013? The FDA Modernization Act of 1997 Thompson versus Western States Medical Center Are We Making Progress? So Where Are We? Blue State, Purple State, Red State-Now It Makes Sense How H.R. 3204 Became Law Once Again, What Just Happened-and How Did We Get to the Drug Quality and Security Act? Quick Level Set of Definitions The States-Tag, You're It! Summary Endnotes The World of Human Drug Compounding: Hope and Change What Is Pharmacy Compounding? A Look at Compounded Drugs/Medications Drug Quality and Security Act Food and Drug Modernization Act of 1997 and 503A Revisited FDA Trials: Why Exemptions Are a Big Deal Title I: Pharmacy Compounding and 503B Traditional Compounding And We Have Liftoff-Maybe Issues to Be Resolved Governance and Leadership Governance, Leadership, and the NECC Summary Endnotes Pharmacy Compounding: The Supply Chain World Pharmacy Compounding Supply Chain Defined From Patient/Doctor Prescription to Ingredients From APIs and Compounding Ingredients to Compounded Medicines Summary Endnotes Track and Trace: Not Hide and Seek Overview From Planning to Execution Back to the Future The Silver Lining: Serialization The Silver Lining: Track and Trace Technology The Silver Lining: The Authentication Connection Enter the Bad Guys-and Gals Authentix ePedigree: Act 2? Where Do We Go from Here? Summary Endnotes Land of the Giants-and Land of the Totes Overview The Big Three McKesson Company: The Largest and the Oldest AmerisourceBergen Cardinal Health Why the History Perspective of the Big Three? Back to Standing in Line for a Prescription The Drug Quality and Security Act: Wholesale Distributors Transaction Information and Transaction History The Big Three and Technology The Other 15% Wholesale Distributors, Repackaging, and the Drug Quality and Security Act Transaction Statement Problems in 2012 Other Problems Summary Endnotes The Customer/Patient Touchpoint-Literally and Electronically: Internet Pharmacies, Pill Mills, and Other Lurking Dangers Overview Drug Quality and Security Act and Local Pharmacies The Pharmacy Prescription Order-Fill Process The Legal Online Prescription Order-Fill Process The Illegal Internet Prescription Order-Fill Process Legal versus Illegal Internet Pharmacies Why Do Internet Pharmacies Exist? The FDA, the U.S. Justice Department, and Internet Pharmacies The Drug Quality and Security Act and Illegal Internet Pharmacies Why a Courier Service? Illegal Internet Pharmacies and Courier Services Back to the Drug Quality and Security Act and the FFDCA Pill Mills Local Pharmacies and Pill Mills CVS Pharmacy in Sanford, Florida Walgreens Settlement Summary Endnotes When Things Go Bump in the Night: Reverse Logistics Overview What Is Reverse Logistics? The Human Factor Enter Stage Right: Reverse Distributors and Third-Party Logistics Providers Why Do Reverse Distributors Exist? The Drug Quality and Security Act: Back to Third-Party Logistics Providers Reverse Distributors The Physical Process of Returns Title II and the Value of Returns What Are the Critical Inhibitors? Summary Endnotes All Those "Lettered" Government Agencies Overview The Federal and State Boys and Girls U.S. Food and Drug Administration U.S. Drug Enforcement Administration The State Boards of Pharmacy The State Departments of Public Safety The State Medical Boards Summary Endnotes Pulling It All Together: Public Policy and Other Items of Note Overview Public Policy Innovation Drug Shortages Faster FDA Trials and Drug Shortages Ebola, FDA Trials, and Public Policy Pharmaceutical Drug Companies and the Drug Quality and Security Act Trucking Companies and the Drug Quality and Security Act One Barrier between Patients and Adulterated and Counterfeit Drugs: Nurses Summary-Title I: Compounding Quality Act Summary-Title II: Drug Supply Chain Security Act Conclusion Endnotes Drug Quality and Security Hall of Fame Introduction David Sparks, Founder of PCCA The Eli Lilly Family John McKesson, Founder, Neil E. Harmon and Alan Seelenfreund, CEOs, McKesson and Company Herb Sheer: GENCO-Third Generation Dr. Harvey W. Wiley, FDA Legislature-Fred Upton David Joseph Ballard, Chief Quality Officer, Baylor Scott & White Health Summary Endnotes

About the Author

Karl F. Kuglin is a professional services consultant with Ernst & Young LLP in the EY Life Sciences industry group. He helps pharmaceutical companies to adapt and lead change to the industry, including emerging science, new products and services, shifting demographics, evolving regulations (such as the Drug Quality and Security Act), transforming business models, and increased stakeholder expectations. Kuglin has operational leadership experience with one of the leading return logistics companies in the pharmaceutical industry. This experience includes an in-depth knowledge of the regulations governing pharmaceutical drugs (including controlled substances). He led a team responsible for the receipt, processing, return to manufacturer, and destruction of returned pharmaceutical drugs, and the accuracy of the application for credit allowances to pharmaceutical manufacturers. His contribution to Chapter 7, "When Things Go Bump in the Night: Reverse Logistics," was invaluable. Kuglin is a graduate of Indiana University with a major in business administration.

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