Essentials of Pharmacy Law
Features
Summary
This book examines the laws and regulations relating to the practice of pharmacy, and the regulation and control of drugs cosmetics, and medical devices. Most available pharmacy law texts thus far have been written by lawyers and present heavy, dense, legalistic reading that focuses on legal theory. Essentials of Pharmacy Law is written by a practicing pharmacist in clear, accessible, contemporary prose that concentrates on application.
This user-friendly text is a compilation and commentary of selected federal laws and regulations pertaining to the general practice of pharmacy in the United States. It covers topics in a simple and concise format. Furthermore, case studies and review questions and a bulleted summary of key points make for easy reading and aid in comprehension.
Essentials of Pharmacy Law will be extremely useful to senior pharmacy students preparing for the Multi-State Jurisprudence Exam (NABLEX MJPE). as well as the voluntary Pharmacist Competency Exam offered to practicing pharmacists. It alsoalso serves as a valuable reference for pharmacy students, practicing pharmacists seeking licensure by reciprocity and/or preparing for the MJPE, pharmacy technicians who are in need of a comprehensive update, and other interested healthcare professionals.
Table of Contents
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
Editorial Reviews
"I found that Essentials of Pharmacy Law goes a long way toward meeting its stated goals and successfully covers and explains the essentials of pharmacy law in a very compact, accessible format."
-Mitch Marsh PharmD BCPS, Inpatient Clinical Pharmacy Coordinator, St. Elizabeth Regional Medical Center
