Read more
Informationen zum Autor Albert I Wertheimer, Delbert Konnor Klappentext A primer on the legal aspects of pharmaceutical practice! this book provides 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. It examines the major topics that impact pharmaceutical care. Zusammenfassung A primer on the legal aspects of pharmaceutical practice, this book provides 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. It examines the major topics that impact pharmaceutical care. Inhaltsverzeichnis 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 Pharmacists 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 ...
