Pharmacy Law: Textbook & Review / Edition 1

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A concise review of pharmacy law -- ideal for coursework and MPJE® exam prep!

This accessible, real-world guide gets you ready for the practice of pharmacy, while giving you the proper training to be compliant with the law. To that end, the book expertly covers relevant laws, rules, and regulations, and it highlights the distinctions between state and federal law where appropriate. In no other reference can you find such a succinct, yet thorough, review of the full range of federal pharmacy laws, including the Controlled Substances Act; the Food, Drug, and Cosmetics Act; the new Dietary Supplement Health Education Act; the FDA Modernization Act; and the Medicare Modernization Act.


• Opening chapter on drug regulation and standards provides you with a practical legal framework for subsequent chapter material

• Overview of the drug approval process and federal reporting programs

• Chapter on internet sales and FDA authority to act

• Coverage of opioid addiction treatment and narcotic treatment programs

• Comprehensive set of 450+ MPJE(R)-format practice questions and answers

• A CD-ROM that reprises the practice questions to provide a board-simulating interface

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Editorial Reviews

Doody's Review Service
Reviewer: Barbara L Giacomelli, PharmD., MBA (McKesson Provider Technologies)
Description: This book outlines key points of relevant federal laws and regulations that apply to pharmacy. It does not provide details related to individual states.
Purpose: The purpose of the book and companion CD-ROM is to provide a study guide for pharmacy students preparing for the law exam component for licensure. The book meets its objectives and the CD is a nice way to provide practice tests.
Audience: Pharmacy students preparing to take the licensure exam are the intended audience. The author is a pharmacist and a lawyer.
Features: The book references key federal legislation and regulations that apply to pharmacy. It summarizes the important points, including how a drug comes to market, how to legally obtain medications, and regulations in place to ensure patient safety. The only shortcoming is that the Chapter on USP797 is out of date, since new standards were released in December 2007 that become effective in June 2008.
Assessment: This is a consolidated view of federal regulations and standards that govern the practice of pharmacy. It is a compact reference and study guide which may be beneficial to students preparing for the pharmacy boards. Alternatives to the book include the Internet, where the complete standards and regulations can be found, or other more comprehensive pharmacy law books, used in teaching at pharmacy schools. However, this book offers concise information and a CD of practice test questions, a great tool for preparing for the boards.
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Product Details

  • ISBN-13: 9780071486354
  • Publisher: McGraw-Hill Professional Publishing
  • Publication date: 11/18/2007
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 416
  • Product dimensions: 7.30 (w) x 9.10 (h) x 0.54 (d)

Meet the Author

Debra B. Feinberg, RPh, BS Pharm, JD

Executive Director

New York State Council of Health-system Pharmacists

Associate Adjunct Professor, Jurisprudence

Albany College of Pharmacy

Albany, NY

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Table of Contents

1. Drug Regulation and Standards

2. The History of Federal Pharmacy Drug Laws: A Timeline of Drug Law
3. The Drug Approval Process
4. Federal Reporting Programs
5. Prescription to Over-the-Counter Switch
6. Substitution of Drug Products
7. Medical Devices, Cosmetics, Homeopathic, and Dietary Supplements
8. Product Recall
9. Drug Product Labeling
10. Antitampering and Poison Prevention Packaging
11. Good Manufacturing Practices and Expiration Dating
12. Omnibus Budget Reconciliation Act of 1990
13. Labeling of Over-the-Counter Drug Products
14. Federal Controlled Substance Law
15. FDA Authority and Internet Sales
16. Opioid Addiction Treatment and Methadone Use
17. Combat Methamphetamine Epidemic Act
18. United States Postal Service Mailing Requirements for Controlled Substances
19. Health Insurance Portability and Accountability Act of 1996
20. USP Chapter
21. Bar Coding
22. Regulation of Pharmacy Practice
23. Multistate Pharmacy Jurisprudence Exam
24. Medicare Prescription Drug Improvement and Modernization Act of 2003

Review Questions and Answers
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