The Drug Supply Chain Security Act Explained Second Edition Plus Explanations Of Key FDA DSCSA Guidances

The Drug Supply Chain Security Act (DSCSA) was passed by Congress in the fall of 2013 and signed into law by President Barack Obama on November 27, 2013. The DSCSA was Title II of the Drug Quality and Security Act (DQSA). The law establishes new requirements that must be administered by the Food and Drug Administration (FDA). These requirements escalate over time from 2015 through 2023 in a series of stages. They include lot-based tracing of prescription pharmaceuticals from the manufacturer to the dispenser from 2015 through 2023 and serialization-based tracing after 2023. Drug manufacturers must apply unique identifiers on all prescription drug packages by November 2017 and repackagers, wholesale distributors and dispensers must begin to buy and sell products marked with those identifiers by November of 2018, 2019 and 2020 respectively.

This book explains the DSCSA, section by section, so that drug manufacturers, repackagers, wholesale distributors, dispensers, contract partners (CMOs, CPOs, 3PLs), solution providers, consultants, law firms, regulators and students can understand the text, the meaning and the significance of the law.

The book also includes more than two dozen of the most informative RxTrace essays about various aspects of the DSCSA. These essays, by Dirk Rodgers, help to expose the implications of the law and provide the context necessary to understand its full impact on companies in the supply chain. In these essays, the latest FDA guidance related to the DSCSA, as of book publication, are explained.

Praise for The Drug Supply Chain Security Act Explained, Second Edition:

"Dirk Rodgers has an unparalleled knowledge of federal track and trace legislation. This book is essential reading for anyone who wants to understand and benefit from coming changes to the pharmaceutical supply chain." -- Adam J. Fein, Ph.D., president, Pembroke Consulting, Inc., and CEO, Drug Channels Institute

"Through RxTrace, Dirk Rodgers has provided stakeholders valuable insights on DSCSA. As DSCSA has evolved, his questions and opinions have helped all the stakeholders understand compliance. Dirk's new book brings years of wisdom from RxTrace and more together in one volume." -- Napoleon Monroe, Managing Director, New Directions Technology Consulting, LLC

"As dispensers entrusted with the last encounter for patient safety, it is important to have a venue for discussion on DSCSA implementation challenges amongst trading partners. In this book, Dirk provides his experience as a resource for companies to use to create solutions." -- Chris Chandler, PharmD, VP of USDM Healthcare