Main description:

Your primary source for information on the legal issues of pharmaceutical practice, care, and activity

Today's pharmacist is faced with legal, ethical, and moral concerns in making the transition from traditional pharmacy practice to an expanded role in clinical pharmacy and patient drug management services. Pharmacy Law Desk Reference is a primer on the legal aspects of pharmaceutical practice, providing background on foundational legal concepts, and guidance on the Food, Drug, and Cosmetic Act (FDCA), the Controlled Substances Act (CSA), and the Federal Trade Commission. This unique book examines the major topics that impact pharmaceutical care, including professional liability insurance; the need for supportive personnel in pharmacy practice; patent law, trademarks, and copyrights; law and ethics; business law; HIPAA privacy in the pharmacy; electronic prescribing; and medication error reporting. Handy tables, figures, and exhibits make complex information easy to access and understand.

The better pharmacists understand the regulatory and legislative framework that shapes their practice, the better they will be able to carry out their responsibilities to patients. Pharmacy Law Desk Reference offers a broad scope on established legal subjects, the current direction of the profession, and important contemporary topics that affect the clinical role of the practicing pharmacist. Each chapter is authored by a nationally recognized authority on one or more aspect of pharmacy law and many of the contributors are active in the American Society of Pharmacy Law.

Topics addressed in Pharmacy Law Desk Reference include:

telepharmacy

collaborative drug therapy management

trade secrets and trade secret protection

anti-competitive practices

the threat of civil and criminal liability

the Health Insurance Portability and Accountability Act of 1996 (HIPAA)

FDA inspections

consumer protection laws

credentialing

pharmacy compounding

accreditation

employment contracts

Medicaid and Medicare

controlled substance registration and prescription orders

forged prescription orders

and many more

Pharmacy Law Desk Reference is a comprehensive resource on the professional, legal, and contemporary issues in pharmacy practice. It is a primary reference guidebook for pharmacy practitioners, leaders of state and national pharmacists associations, members of state boards of pharmacy, educators and students, and an essential addition to all pharmacy libraries.

Contents:

About the Editor

Contributors

Foreword (Joseph G. Valentino)

Preface (Delbert D. Konnor)

Chapter 1. The Function, Evolution, and Historical Development of the Law (Martha M. Rumore)

Government Organization and Function

Agency Organization and Function

The Court System

Order of Precedence of Authority

Enactment of Legislation

Code of Federal Regulations

Secondary Sources of the Law

Appendix: Electronic Resources

Chapter 2. Forms of Business Organization (Francis B. Palumbo and George Rippel, Jr.)

Introduction

Forms of Organization

Piercing the Corporate Veil

Conclusion

Chapter 3. Federal Food, Drug, and Cosmetic Act (Larry R. Pilot)

Introduction

History

Food and Drug Administration

Surveillance, Enforcement, and Resolution

Department of Justice, Civil Division

Provisions of FFDCA Directly Applicable to Pharmacists and Pharmacies

Summary

Chapter 4. The Pharmacist's Responsibility Under the Controlled Substances Act and Related Matters (Delbert D. Konnor)

Background

Schedules of Controlled Substances

Registration Requirements

Disposal of Controlled Substances

Security Requirements

Record-Keeping Requirements

Change of Business Address

Affidavit for Renewal of Retail Chain Pharmacy Registration

Prescription Order Requirements

Prescription Monitoring Programs

Prescription Records

Inventory Requirements

Ordering Controlled Substances

Dispensing Requirements

Long Term Care Facilities

Controlled Substance Distribution by a Pharmacy

Narcotics for Patients with Terminal Illnesses of Intractable Pain

Narcotic Treatment Programs

U.S. Postal Service Mailing Requirements for Controlled Substances

Controlled Substances for Medical Missions and Humanitarian Charitable Solicitations

Chemical Requirements: Comprehensive Methamphetamine Control Act of 1996

Pharmacists' Guide to Forged, Altered, and Stolen Prescription Blanks

Appendix: DEA Field Offices with Diversion Program Managers

Chapter 5. Principles of Professional Liability Insurance for Pharmacists (Kenneth R. Baker)

Overview

Underwriting

Professional Pharmacy Liability Coverage

Reading a Professional Liability and Commercial Policy

Conclusion

Chapter 6. Patent Law, Trademarks, and Copyrights (Martha M. Rumore)

Trade Dress

Patents

Trademarks

Nonpatent Protection

Copyright

Chapter 7. Pharmacy Trade Regulation (Richard A. Feinstein and Daniel A. Kotchen)

Antitrust Laws

Antitrust Law Enforcement Mechanisms and Penalties

Antitrust Enforcement in the Pharmaceutical Industry

Minimizing Antitrust Risk

Consumer Protection Laws

Chapter 8. Administrative Law (Sharon Horn Roddan)

Introduction

The Need for Administrative Tribunals

Separation of Powers

Delegation of Legislative Powers

Due Process Hearing Requirement

The Right To and Adequacy of Notice

The Process of Administrative Adjudication

Chapter 9. Professional Practice Acts (Norman A. Campbell)

Establishing the Practice Parameters

General Provisions of a Pharmacy Practice Act

The Board of Pharmacy

Additional Provisions of the Act

Pharmacist Licensing Requirements

License Renewal

Pharmacy Technicians

Licensing Entities

Board Sanctions Against Licenses

Chapter 10. Labor and Employm