Pharmaceutical Supply Chain

Drug Quality and Security Act

Fred A. Kuglin (Kuglin, Inc., Plano, Texas, USA)

$162

Hardback

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English

CRC Press Inc
29 July 2015

Production & quality control management; Pharmaceutical industries; Regulation of medicines & medical devices; Pharmacy & dispensing

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.

By: Fred A. Kuglin (Kuglin Inc. Plano Texas USA)
Imprint: CRC Press Inc
Country of Publication: United States
Dimensions: Height: 234mm, Width: 156mm, Spine: 18mm
Weight: 453g
ISBN: 9781482258936
ISBN 10: 1482258935
Pages: 206
Publication Date: 29 July 2015
Audience: General/trade , College/higher education , ELT Advanced , Primary
Format: Hardback
Publisher's Status: Active

"H.R. 3204 – The Journey and Expected Destination. The World of Human Drug Compounding – Hope and Change! Pharmacy Compounding – The Supply Chain World. Track and Trace – Not Hide & Seek! Land of the Giants – and Land of the Totes! The Customer/Patient Touchpoint – Literally and Electronically! When Things Go Bump In The Night: Reverse Logistics. All Those ""Lettered"" Government Agencies. Pulling It All Together: Public Policy and Other Items of Note. Drug Quality and Security Hall of Fame."

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.