Essentials of Pharmacy Law: 1st Edition (Paperback) book cover

Essentials of Pharmacy Law

1st Edition

By Douglas J. Pisano

Routledge

136 pages | 7 B/W Illus.

Purchasing Options:$ = USD
Paperback: 9781566769181
pub: 2002-07-29
$86.95
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Hardback: 9781138457331
pub: 2017-08-15
$200.00
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Description

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.

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

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

About the Series

Pharmacy Education Series

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy