Pharmaceutical Supply Chain : Drug Quality and Security Act (Paperback)

Introduction: The Good, the Bad, the Ugly, and the NecessaryWho Gives It a Second Thought?The Pharma Industry: The Good?Positive Impact on Human LifeThe Pharma Industry: The Bad?Negative Impact on Human LifeRecalls?A Way of LifeThe Pharma Industry: The Ugly?Human Life LostThe Pharma Industry: The Necessary?The Drug Quality and Security Act (H.R. 3204)The Book ChaptersEndnotesH.R. 3204: The Journey and Expected DestinationHow Did We Get to November 27, 2013?The FDA Modernization Act of 1997Thompson versus Western States Medical CenterAre We Making Progress?So Where Are We?Blue State, Purple State, Red State?Now It Makes SenseHow H.R. 3204 Became LawOnce Again, What Just Happened?and How Did We Get to the Drug Quality and Security Act?Quick Level Set of DefinitionsThe States?Tag, You’re It!SummaryEndnotesThe World of Human Drug Compounding: Hope and ChangeWhat Is Pharmacy Compounding?A Look at Compounded Drugs/MedicationsDrug Quality and Security ActFood and Drug Modernization Act of 1997and 503A RevisitedFDA Trials: Why Exemptions Are a Big DealTitle I: Pharmacy Compounding and 503BTraditional CompoundingAnd We Have Liftoff?MaybeIssues to Be ResolvedGovernance and LeadershipGovernance, Leadership, and the NECCSummaryEndnotesPharmacy Compounding: The Supply Chain WorldPharmacy Compounding Supply Chain DefinedFrom Patient/Doctor Prescription to IngredientsFrom APIs and Compounding Ingredients to Compounded MedicinesSummaryEndnotesTrack and Trace: Not Hide and SeekOverviewFrom Planning to ExecutionBack to the FutureThe Silver Lining: SerializationThe Silver Lining: Track and Trace TechnologyThe Silver Lining: The Authentication ConnectionEnter the Bad Guys?and GalsAuthentixePedigree: Act 2?Where Do We Go from Here?SummaryEndnotesLand of the Giants?and Land of the TotesOverviewThe Big ThreeMcKesson Company: The Largest and the OldestAmerisourceBergenCardinal HealthWhy the History Perspective of the Big Three?Back to Standing in Line for a PrescriptionThe Drug Quality and Security Act: Wholesale DistributorsTransaction Information and Transaction HistoryThe Big Three and TechnologyThe Other 15%Wholesale Distributors, Repackaging, and the Drug Quality and Security ActTransaction StatementProblems in 2012Other ProblemsSummaryEndnotesThe Customer/Patient Touchpoint?Literally and Electronically: Internet Pharmacies, Pill Mills, and Other Lurking Dangers OverviewDrug Quality and Security Act and Local Pharmacies The Pharmacy Prescription Order-Fill ProcessThe Legal Online Prescription Order-Fill ProcessThe Illegal Internet Prescription Order-Fill ProcessLegal versus Illegal Internet PharmaciesWhy Do Internet Pharmacies Exist?The FDA, the U.S. Justice Department, and Internet PharmaciesThe Drug Quality and Security Act and Illegal Internet PharmaciesWhy a Courier Service?Illegal Internet Pharmacies and Courier ServicesBack to the Drug Quality and Security Act and the FFDCAPill Mills Local Pharmacies and Pill MillsCVS Pharmacy in Sanford, FloridaWalgreens SettlementSummaryEndnotes When Things Go Bump in the Night: Reverse LogisticsOverviewWhat Is Reverse Logistics?The Human FactorEnter Stage Right: Reverse Distributors and Third-Party Logistics ProvidersWhy Do Reverse Distributors Exist?The Drug Quality and Security Act:Back to Third-Party Logistics ProvidersReverse DistributorsThe Physical Process of ReturnsTitle II and the Value of ReturnsWhat Are the Critical Inhibitors?SummaryEndnotesAll Those "Lettered" Government AgenciesOverviewThe Federal and State Boys and GirlsU.S. Food and Drug AdministrationU.S. Drug Enforcement AdministrationThe State Boards of PharmacyThe State Departments of Public SafetyThe State Medical BoardsSummaryEndnotesPulling It All Together: Public Policy and Other Items of NoteOverviewPublic PolicyInnovationDrug ShortagesFaster FDA Trials and Drug ShortagesEbola, FDA Trials, and Public PolicyPharmaceutical Drug Companiesand the Drug Quality and Security ActTrucking Companies and the Drug Quality and Security ActOne Barrier between Patients and Adulterated and Counterfeit Drugs: NursesSummary?Title I: Compounding Quality ActSummary?Title II: Drug Supply Chain Security ActConclusionEndnotesDrug Quality and Security Hall of FameIntroductionDavid Sparks, Founder of PCCAThe Eli Lilly FamilyJohn McKesson, Founder, Neil E. Harmon and Alan Seelenfreund, CEOs, McKesson and CompanyHerb Sheer: GENCO?Third GenerationDr. Harvey W. Wiley, FDALegislature?Fred UptonDavid Joseph Ballard, Chief Quality Officer, Baylor Scott & White HealthSummaryEndnotes