Essentials of Pharmacy Law (Paperback)

INTRODUCTION TO PHARMACY LAW

The Evolution of Pharmacy Practice
Introduction
Meeting the Challenge
The Expanded Role
Pharmacy's Practice Settings

US Drug Regulation
Overview
Brief history of drug laws and regulations
Regulatory Oversight of Pharmaceuticals
New Drug Approval and Development
Pre-Clinical Investigations
Investigational New Drug Applications (INDA)
Phase I
Phase II
Phase III
New Drug Applications (NDA)
PDUFA/FDAMA Effects
Biologics
Orphan Drugs
Abbreviated New Drug Applications (ANDA)
Phase IV and Post Marketing Surveillance
Over-The-Counter (OTC) Regulations
Regulating Marketing
Violations and Enforcement
Summary

Federal Laws and Regulations Governing Pharmacy, Pharmacists, and Prescriptions
A Comprehensive Overview
Federal versus State Laws and Regulations
Prescription Basics
Product Selection
The Prescription
Prescription Labeling
The Pharmacy
Miscellaneous

DEA Registration
Who May Be Issued a DEA Registration?
DEA Registration Numbers
Registration
Transferring a Pharmacy Business
Practitioners
Mid-Level Practitioners
Practitioner's Use of a Hospital's DEA Registration Number

Pharmacists Liability and the Legal Issues of OBRA-'90 and Patient Counseling
Introduction
Issues
Prospective Drug Review
Really...What's it all mean?
Conclusion

Pharmaceutical Care: Our Legal and Professional Strategic Plan
The Pew Commission Reports and the Changing Landscape
of Healthcare
Pharmaceutical Care and the Pharmaceutical Care Model
Rudimentary Pharmaceutical Care Equals Counseling!!!!
Pharmaceutical Care and Risk Management
Conclusion

CASE STUDIES IN PHARMACY LAW
Controlled Substances Act
Controlled Substances Act
Controlled Substances Act
Controlled Substances Act
Controlled Substances Act
OBRA '90
OBRA '90
Product Selection
Food, Drug and Cosmetic Act
Food, Drug and Cosmetic Act
Prescription Drug Marketing Act
Mid-Level Practitioners
Poison Prevention Packaging Act
Expiration Dating and NDC Code
Over-the-Counter Drugs

EXAM REVIEW QUESTIONS

DEA FORMS
Application for Registration
Registrants Inventory of Drugs Surrendered
Report of Theft or Loss of Controlled Substances
DEA Form-222
Index