Pharmaceutical Supply Chain

Editor/Author Kuglin, Fred A.
Publication Year: 2015
Publisher: CRC Press

Single-User Purchase Price: $79.95
Unlimited-User Purchase Price: Not Available
ISBN: 978-1-48-225893-6
Category: Health & Medicine - Medicine
Image Count: 44
Book Status: Available
Table of Contents

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.

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Table of Contents

  • Preface
  • Acknowledgments
  • Author
  • Introduction: The Good, the Bad, the Ugly, and the Necessary
  • Chapter 1 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!
  • Massachusetts: Their Response
  • Michigan: Representative Fred Upton's State
  • California
  • Florida
  • Colorado
  • Texas
  • Summary
  • Chapter 2 The World of Human Drug Compounding: Hope and Change
  • What Is Pharmacy Compounding?
  • A Look at Compounded Drugs/Medications
  • Example of Nonsterile, Traditional Compounding
  • Example of Sterile Compounding for Office Use
  • Summary
  • 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
  • Outsourcing Facility Registration and Reporting
  • Traditional Compounding
  • And We Have Liftoff—Maybe
  • Issues to Be Resolved
  • Governance and Leadership
  • Governance, Leadership, and the NECC
  • Summary
  • Chapter 3 Pharmacy Compounding: The Supply Chain World
  • Pharmacy Compounding Supply Chain Defined
  • From Patient/Doctor Prescription to Ingredients
  • PCCA: Overview
  • Order Aggregation and Supplier Sourcing
  • Order Placement, Supplier Base Compound Shipment and PCCA Receipt
  • The Drug Quality and Security Act
  • Compounding Pharmacy Order Fill
  • From APIs and Compounding Ingredients to Compounded Medicines
  • The Complication
  • Good Manufacturing Practices: The Foundation to Ensure a Safe and Sterile Environment
  • Are We There Yet?
  • One Best Practice to Model
  • The Best Defense Is a Good Offense
  • Back to PCCA
  • Eagle Analytical Services
  • PCCA and the AIB Industry Audit Solution for Compounding Pharmacies
  • Summary
  • Chapter 4 Track and Trace: Not Hide and Seek
  • Overview
  • Key Provisions
  • Product Identification
  • Product Tracing
  • Product Verification
  • Detection and Response
  • Notification
  • Wholesale Distributor Licensing
  • Third-Party Logistics Provider Licensing
  • 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
  • Chapter 5 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
  • Chapter 6 The Customer/Patient Touchpoint—Literally and Electronically: Internet Pharmacies, Pill Mills, and Other Lurking Dangers
  • Overview
  • Drug Quality and Security Act and Local Pharmacies
  • Pharmacy Prescription Order-Fill Process
  • Legal Online Prescription Order-Fill Process
  • 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
  • Chapter 7 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
  • Saleable Returns
  • Unsaleable Returns
  • Title II and the Value of Returns
  • What Are the Critical Inhibitors?
  • Organizational Levels Involved
  • Availability and Access to Relevant Data
  • Incentives
  • Summary
  • Chapter 8 All Those “Lettered” Government Agencies
  • Overview
  • The Federal and State Boys and Girls
  • U.S. Food and Drug Administration
  • Troubling Marketplace
  • The 1906 Pure Food and Drug Act (The Wiley Act)
  • Enforcing the Wiley Act
  • The Federal Food, Drug, and Cosmetic Act
  • The Preventive Amendments
  • The 1962 Kefauver-Harris Amendment
  • The 1988 Food and Drug Administration Act
  • The Prescription Drug Marketing Act of 1988
  • Food and Drug Administration Modernization Act of 1997
  • FDA Summary
  • U.S. Drug Enforcement Administration
  • History: Controlled Substances Act and the DEA
  • Overview/Mission
  • Responsibilities
  • Offices/Sections
  • The DEA Office of Diversion Control
  • The CBP and the DEA
  • DEA National Prescription Drug Take-Back Day
  • DEA Summary
  • State Boards of Pharmacy
  • State Departments of Public Safety
  • State Medical Boards
  • Summary
  • Chapter 9 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
  • Chapter 10 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