Securing the pharmaceutical supply chain : issues and perspectives / Lenora White, editor.

Format:

Book

Contributor:

White, Lenora, editor.

Series:

Pharmacology - Research, Safety Testing and Regulation

Language:

English

Subjects (All):

Pharmaceutical industry--Materials management--United States.

Pharmaceutical industry.

Product counterfeiting--United States--Prevention.

Product counterfeiting.

Drug adulteration--United States--Prevention.

Drug adulteration.

Physical Description:

1 online resource (109 p.)

Edition:

First edition.

Place of Publication:

New York : Nova Science Publishers, Inc., [2015]

Summary:

The drug package that a community pharmacist hands to a patient, or a hospital pharmacist sends to a patient's bedside, or a physician administers in the medical office has reached the end of a complicated path. That path is called a supply or distribution chain. The upstream portion of the chain includes the journey of each active and inactive ingredient and their chemical components to the manufacturer that creates the finished drug product. The downstream chain, which this report addresses, includes the repackagers, wholesale distributors, associated storage and transport companies, and, fi

Contents:

SECURING THE PHARMACEUTICAL SUPPLY CHAIN: ISSUES AND PERSPECTIVES; SECURING THE PHARMACEUTICAL SUPPLY CHAIN: ISSUES AND PERSPECTIVES; Library of Congress Cataloging-in-Publication Data; Contents; Preface; Chapter 1: Pharmaceutical Supply Chain Security; Summary; Pharmaceutical Supply Chain:; Why People Care; Pharmaceutical Supply Chain: How It Works; How Congress; Has Moved to Regulate; the Supply Chain; Prescription Drug Marketing Act of 1987; Food and Drug Administration Amendments Act of 2007; Food and Drug Administration Safety and Innovation Act of 2012; State Activity

Professional and Industry Association ActivityPolicy Decision Points; Concluding Comments; End Notes; Chapter 2: Statement of Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA. Hearing on ''Securing Our Nation's Prescription Drug Supply Chain''; Introduction; Securing the Supply Chain for Prescription Drugs; FDA's Current Activities; Next Steps; Conclusion; Chapter 3: Testimony of Elizabeth A. Gallenagh, Vice President, Government Affairs, Healthcare Distribution Management Association. Hearing on ''Securing Our Nation's Prescription Drug Supply Chain''

Chapter 4: Testimony of Christine Simmon, Senior Vice President, Policy & Strategic Alliances, Generic Pharmaceutical Association. Hearing on ''Securing Our Nation's Prescription Drug Supply Chain''Introduction; Uniform Federal Standard; Achievability; Building-Block Approach; Conclusion; Chapter 5: Testimony of Michael Rose, Vice President, Supply Chain Visibility, Johnson and Johnson Health Care Systems, Inc. Hearing on ; Chapter 6: Testimony of Tim Davis, Owner, Beaver Health Mart Pharmacy. Hearing on ''Securing Our Nation's Prescription Drug Supply Chain''

Chapter 7: Testimony of Allan Coukell, Director, Medical Programs, The Pew Charitable Trusts. Hearing on ''Securing Our Nation's Prescription Drug Supply Chain''Verification to Prevent Drug Diversion; Key Elements of a National System; Unit Level Serialization and Traceability; Routine Checking of Drug Serial Numbers; Conclusion; End Notes; Chapter 8: Testimony of Carmen A. Catizone, Executive Director, National Association of Boards of Pharmacy. Hearing on ''Securing Our Nation's Prescription Drug Supply Chain''(; Twenty Five Years of "Proposed" and" Delayed"

The States Serve as the Last Defense for Patients and ConsumersRecommendations; Conclusion; Chapter 9: Statement of Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA. Hearing on ''Securing The Pharmaceutical Supply Chain''(; Introduction; Steps to Secure Our Nation's Drug Supply Chain; After Heparin; Drug Safety Authorities; Leveling the Playing Field; Increasing Drug Safety; Increasing Information; Conclusion

Chapter 10: Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain. Statement of Marcia Crosse, Director, Health Care, U.S. Government Accountability Office. Hearing on ''Securing the Pharmaceutical Supply Chain''

Notes:

Description based upon print version of record.

Description based on publisher supplied metadata and other sources.

Description based on print version record.

ISBN:

9781634634496

1634634497

OCLC:

898279168