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This is the first edition of Pharmacy Law: Textbook and Review. As an Assistant Adjunct Professor at Albany College of Pharmacy in Albany, New York for the past seven years, I have taught Jurisprudence to the fifth year PharmD class. My primary goal in teaching Jurisprudence is to prepare students for the Pharmacy Boards. The goal of this book is to prepare you to be successful in your endeavor to pass the federal portion of the Pharmacy Boards. For those of you who have been successful in passing the Pharmacy Boards, this book will serve as a reference tool as you advance the practice of pharmacy.The book is divided into topics including a description of the federal entities that guide and regulate the practice of pharmacy; a history of pharmacy law; a demonstration of the drug approval process; a review of drug product substitution; a comprehensive review of the controlled substances act; a review of opioid treatment; an overview of medical devices, dietary supplements, herbals, homeophathics, and cosmetics; drug product packaging and labeling; and other regulations such as HIPPA, USP 797, bar coding, and the methamphetamine act. Where possible each chapter provides web sites helpful in further discussion of the topic.
Content:-
Preface
Chapter 1: Drug Regulation and Standards
Chapter 2: The History of Federal Pharmacy Drug Laws: A Timeline of Drug Law
Chapter 3: The Drug Approval Process
Chapter 4: Federal Reporting Programs
Chapter 5: Prescription to Over-the-Counter Switch
Chapter 6: Substitution of Drug Products
Chapter 7: Medical Devices, Cosmetics, Homeopathic, and Dietary Supplements
Chapter 8: Product Recall
Chapter 9: Drug Product Labeling
Chapter 10: Antitampering and Poison Prevention Packaging
Chapter 11: Good Manufacturing Practices and Expiration Dating
Chapter 12: Omnibus Budget Reconciliation Act of 1990
Chapter 13: Labeling of Over-the-Counter Drug Products
Chapter 14: Federal Controlled Substance Law
Chapter 15: FDA Authority and Internet Sales
Chapter 16: Opioid Addiction Treatment and Methadone Use
Chapter 17: Combat Methamphetamine Epidemic Act
Chapter 18: United States Postal Service Mailing Requirements for Controlled Substances
Chapter 19: Health Insurance Portability and Accountability Act of 1996
Chapter 20: USP Chapter <797>
Chapter 21: Bar Coding
Chapter 22: Regulation of Pharmacy Practice
Chapter 23: Multistate Pharmacy Jurisprudence Exam
Chapter 24: Medicare Prescription Drug Improvement and Modernization Act of 2003
Review Questions and Answers
Index
Author Details
"Debra B. Feinberg"
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