000			07367nam a22002297a 4500
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005			20220214175331.0
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020			_a9781032179698
082			_a338.4761510973 _bKUG
100			_aKuglin, Fred A. _94746
245			_aPharmaceutical supply chains: drug quality and security act
260			_bCRC Press _aBoca Raton _c2021
300			_axxx, 176 p.
365			_aGBP _b29.99
504			_aTable 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
520			_aBook Description Error-proofing in the production process of pharmaceuticals isn’t just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Security Act overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights. The book focuses on the delicate balance between protecting the public through legislation against negligent compounding pharmacies and protecting patients by assuring a supply of needed compounded drugs by not over-regulating the industry. The author discusses lessons learned from the earlier e-pedigree initiatives, the technology advances that enable supply chain security, and how the industry will need to respond to the myriad of threats facing the pharmaceutical drug supply chain and comply with this act. He goes in depth into each segment of the pharmaceutical drug supply chain, describing the industry segment and how it will need to adapt to the new act. By incorporating real-world examples of industry leaders, the book underlines the contributions of individuals who have made a difference through innovations and execution. It also addresses how laws are made, and specifically how the Drug Quality and Security Act was passed by Congress and signed into law. In an industry that is so big, you may feel that you cannot make a difference. This book provides you with key insights on how the forward supply chain process should work and how anyone can make a difference at all levels.
650			_aPharmaceutical industry--Quality control _95344
650			_aIndustrial procurement _91510
650			_aBusiness logistics _9435
650			_aDrugs--Law and legislation _95345
942			_2ddc _cBK