Pharmaceutical Supply Chain: Drug Quality and Security Act, 1st Edition (Hardback) book cover

Pharmaceutical Supply Chain

Drug Quality and Security Act, 1st Edition

By Fred A. Kuglin

CRC Press

206 pages | 44 B/W Illus.

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pub: 2015-07-29
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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.

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


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!



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



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



Track and Trace: Not Hide and Seek


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


ePedigree: Act 2?

Where Do We Go from Here?



Land of the Giants—and Land of the Totes


The Big Three

McKesson Company: The Largest and the Oldest


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



The Customer/Patient Touchpoint—Literally and Electronically: Internet Pharmacies, Pill Mills, and Other Lurking Dangers


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



When Things Go Bump in the Night: Reverse Logistics


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?



All Those "Lettered" Government Agencies


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



Pulling It All Together: Public Policy and Other Items of Note


Public Policy


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



Drug Quality and Security Hall of Fame


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



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.

Subject Categories

BISAC Subject Codes/Headings:
BUSINESS & ECONOMICS / Quality Control
BUSINESS & ECONOMICS / Purchasing & Buying
BUSINESS & ECONOMICS / Government & Business
MEDICAL / Administration