Full 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
