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ISBN10: 0071486356 | ISBN13: 9780071486354

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Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. 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. Features:
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 <797>
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
Index
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 <797>
21. Bar Coding
22. Regulation of Pharmacy Practice
23. Multistate Pharmacy Jurisprudence Exam
24. Medicare Prescription Drug Improvement and Modernization Act of 2003
Index
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