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
- 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
Biography
Albert I Wertheimer, Delbert Konnor
