لایب سان

Ebook details:
عنوان: Pharmacy Practice and the Law
نویسنده: Medicine & Health Science Books @ Amazon.com
ناشر: Jones & Bartlett Learning; 9 edition (February 1, 2019)
زبان: English
شابک: 1284154971, 978-1284154979
حجم: 9 Mb
فرمت: True Pdf

9781284154993 1284154998

Cover Page; Title Page; Copyright Page; Dedication; Brief Contents; Contents; Table of Cases; Preface; A Special Acknowledgment; Reviewers; Chapter 1 The Law and the Legal System; The Nature and Role of Law; Reasons to Regulate Medicinal Drugs; Limits of the Law; Take-Away Points; Study Scenarios and Questions; Sources of U.S. Law; The Constitution of the United States; Law Made by Legislatures: Statutory Law; Law Made by Administrative Agencies; Law Made by the Courts: Common Law; Distinguishing Criminal, Civil, and Administrative Law; Take-Away Points; Study Scenarios and Questions The Legislative ProcessFederal Level; State Level; Take-Away Points; The Judicial Process; The Federal Court System; The State Court System; Civil Court Procedures; Criminal Court Procedures; Case Citation and Analysis; Take-Away Points; Study Scenario and Questions; Federal Versus State Law; Federal Authority to Regulate; State Authority to Regulate; Take-Away Points; Study Scenarios and Questions; Case Studies; Chapter 2 Federal Regulation of Medications: Development, Production, and Marketing; Historical Overview of the Federal Food, Drug, and Cosmetic Act; Pure Food and Drug Act of 1906 Food, Drug, and Cosmetic Act of 1938Durham-Humphrey Amendment of 1951; Food Additives Amendment of 1958; Color Additive Amendments of 1960; Kefauver-Harris Amendment of 1962; Medical Device Amendments of 1976; Orphan Drug Act of 1983; Drug Price Competition and Patent Term Restoration Act of 1984; Prescription Drug Marketing Act of 1987; Safe Medical Devices Act of 1990; The Generic Drug Enforcement Act of 1992; Prescription Drug User Fee Act of 1992; Nutrition Labeling and Education Act of 1990; Dietary Supplement Health and Education Act of 1994 Food and Drug Administration Modernization Act of 1997Medical Device User Fee and Modernization Act of 2002; Food and Drug Administration Amendments Act of 2007; Patient Protection and Affordable Care Act of 2010; FDA Safety and Innovation Act of 2012; Drug Quality and Security Act of 2013; The 21st Century Cures Act of 2016; FDA Reauthorization Act of 2017; Rationale for Federal Drug Regulation; Take-Away Points; Study Scenario and Question; The Food and Drug Administration; Take-Away Points; Study Scenario and Question Defining and Distinguishing Drugs from Foods, Dietary Supplements, Devices, and CosmeticsExplanation of the Law; Foods Versus Drugs; Dietary Supplements Versus Drugs; Drugs Versus Devices; Drugs Versus Cosmetics; Labels and Labeling; Official Compendia; Take-Away Points; Study Scenarios and Questions; Prohibited Acts, Penalties, and Enforcement; Explanation of the Law; Enforcement; Corporate Officer Liability; Product Recalls; Take-Away Points; Study Scenarios and Questions; Adulteration; Explanation of Adulteration; Current Good Manufacturing Practice; Product Tampering; Take-Away Points

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