Preface
Chapter 1 The Law and the Legal System
The Nature and Role of Law
Sources of U.S. Law
The Legislative Process
Distinguishing Criminal, Civil, and Administrative Law
The Judicial Process
Federal Versus State Law
Bibliography
Case Studies
Chapter 2 Federal Regulation of Medications: Development, Production, and Marketing
Historical Overview of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA)
Defining and Distinguishing Drugs from Foods, Dietary Supplements, Devices, and Cosmetics
Prohibited Acts, Penalties, and Enforcement
Adulteration
Misbranding
New Drug Approval
Marketed Unapproved Drugs
Drugs Intended to Treat Serious and Life-Threatening Diseases
Biologics
MedWatch Voluntary Reporting Program
Medical Devices
Cosmetics
Drug Advertising and Promotion
Bibliography
Case Studies
Chapter 3 Federal Regulation of Medications: Dispensing
The Durham-Humphrey Amendment of 1951
Prescription Drug Labeling Information for the Patient
Approved Drugs for Unlabeled Indications
Pharmacy Compounding Versus Manufacturing
The Orange Book and Generic Substitution
Prescription Drug Marketing Act of 1987
Inspections Under the Federal Food, Drug, and Cosmetic Act
Related Laws to the FDCA
Drug Advertising by Pharmacies
References
Bibliography
Case Studies
Chapter 4 The Closed System of Controlled Substance Distribution
State Versus Federal Authority
Classification of Controlled Substances
Authority for Scheduling
Manufacturer Labeling and Packaging
Registration
Security Requirements
Penalties
Pharmacy Inspections
Opioid Treatment Programs
Laws Related to the Controlled Substances Act
References
Bibliography
Case Studies
Chapter 5 Dispensing Controlled Substances
Prescriptions
State Electronic Prescription Monitoring Programs (PMPs) and NASPER
Recordkeeping
Drug Enforcement Administration Order Form 222
Reference
Bibliography
Case Studies
Chapter 6 Federal Regulation of Pharmacy Practice
The Omnibus Budget Reconciliation Act of 1990
Health Insurance Portability and Accountability Act of 1996
Medicare
Medicaid
Medicare/Medicaid Fraud and Abuse Statute
Physician Antiself-Referral Law (The Stark Law)
Federal Regulation of Long-Term Care
Federal Antitrust Laws
Miscellaneous Federal Laws Related to Pharmacy Practice
References
Bibliography
Case Studies
Chapter 7 State Regulation of Pharmacy Practice
Self-Regulation in Pharmacy
Approaches to Regulation
State Boards of Pharmacy
Licensing
Actions Against a License
Actions Against a Pharmacy License
Standards of Practice
Repository or Take-Back Programs
State Hospital Pharmacy Licensure Issues
State Regulation of Long-Term Care
State Regulation of Third-Party Plans
Regulation for Outcomes
Bibliography
Case Studies
Chapter 8 Pharmacist Malpractice Liability and Risk Management Strategies
Legal Procedure
The Malpractice Action
Liability for Failure to Perform Expanded Responsibilities
Risk Management Strategies
The Pharmacist as Risk Manager
Malpractice Insurance
Drug Product Liability
Bibliography
Case Studies
Table of Cases
Glossary
Index
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