Table of Contents

• Free Topics
  • About
  • Long-Term Care Facility Pharmacy
  • Medicaid
  • Misbranding
  • Nonprescription Drug Labeling
  • Overview of Important Developments in Medicaid and Prescription Drug Reimbursement
  • Preface
  • Prescription Drug Coverage
  • Prescription Drug Labeling Information for the Patient
  • Prescriptions
  • Purpose of a Controlled Substance Prescription
  • Use and Disclosure of PHI; Right to Access
• 1. The Law and the Legal System
  • 1. The Law and the Legal System
  • Bibliography
  • Case Studies
    • Case 1-1: People v. Stuart
    • Case 1-2: Cohen v. Missouri Board of Pharmacy
    • Case 1-3: Malan v. Huesemann
    • Case 1-4: Heckler v. Chaney
    • Chapter Slides
  • Federal vs State Law
  • Sources of U.S. Law
  • The Judicial Process
  • The Legislative Process
  • The Nature and Role of the Law
• 2. Federal Regulation of Medications: Development, Production, and Marketing
  • 2. Federal Regulation of Medications: Development, Production, and Marketing
  • Adulteration
  • Bibliography
  • Biologics
  • Case Studies
    • Case 2-1: Nutrilab, Inc., et al. v. Schweiker
    • Case 2-2: United States v. Hiland
    • Case 2-3: United States v. Rutherford
    • Case 2-4: United States v. Caronia
    • Chapter Slides
  • Cosmetics
  • Defining and Distinguishing Drugs from Foods, Dietary Supplements, Devices, and Cosmetics
  • Drug Advertising and Promotion
  • Drugs Intended to Treat Serious and Life-Threatening Diseases
  • Historical Overview of the Federal Food, Drug, and Cosmetic Act
  • Marketed Unapproved Drugs
  • Medical Devices
  • MedWatch Voluntary Reporting Program
  • Misbranding
  • New Drug Approval
  • Prohibited Acts, Penalties, and Enforcement
  • The Food and Drug Administration
• 3. Federal Regulation of Medications: Dispensing
  • 3. Federal Regulation of Medications: Dispensing
  • Approved Drugs for Off-Label (Unlabeled) Indications
  • Bibliography
  • Case Studies
    • Case 3-1: Pharmaceutical Manufacturers Association v. Food and Drug Administration
    • Case 3-2: Ramon v. Farr
    • Case 3-3: Pfizer, Inc. v. Shalala
    • Case 3-4: Winn Dixie of Montgomery, Inc. v. Colburn
    • Case 3-5: Kennedy v. Kentucky Board of Pharmacy
    • Chapter Slides
  • Drug Advertising by Pharmacies
  • Drug Supply Chain Security
  • Inspections Under the Federal Food, Drug, and Cosmetic Act
  • Pharmacy Compounding vs Manufacturing
  • Prescription Drug Labeling Information for the Patient
  • Related Laws to the FDCA
  • Safe Handling of Hazardous Drugs
  • The Durham-Humphrey Amendment of 1951
  • The Orange Book and Generic Substitution
• 4. The Closed System of Controlled Substance Distribution
  • 4. The Closed System of Controlled Substance Distribution
  • Authority for Scheduling
  • Bibliography
  • Case Studies
    • Case 4-1: State v. Rasmussen
    • Case 4-2: Lemmon Company v. State Board of Medical Examiners
    • Case 4-3: United States v. Little
    • Chapter Slides
  • Classification of Controlled Substances
  • Laws Related to the Controlled Substances Act
  • Manufacturer Labeling and Packaging
  • Opioid Treatment Programs
  • Penalties
  • Pharmacy Inspections
  • References
  • Registration
  • Security Requirements
  • State vs Federal Authority
• 5. Dispensing Controlled Substances
  • 5. Dispensing Controlled Substances
  • Bibliography
  • Case Studies
    • Case 5-1: United States v. Hayes
    • Case 5-2: Ryan v. Dan's Food Stores, Inc.
    • Case 5-3: Gordon v. Frost
    • Case 5-4: Daniel Family Pharmacy
    • Case 5-5: Whalen v. Roe
    • Chapter Slides
  • Drug Enforcement Administration Order Form 222
  • Prescriptions
  • Recordkeeping
• 6. Federal Regulation of Pharmacy Practice
  • 6. Federal Regulation of Pharmacy Practice
  • Bibliography
  • Case Studies
    • Case 6-1: American Pharmaceutical Association v. Weinberger
    • Case 6-2: Horner v. Spalitto
    • Case 6-3: Van Iperen v. Van Bramer
    • Case 6-4: Harder v. F. C. Clinton, Inc.
    • Chapter Slides
  • Federal Antitrust Laws
  • Federal Regulation of Long-Term Care
  • Health Insurance Portability and Accountability Act of 1996
  • Medicaid
  • Medicare
  • Medicare/Medicaid Fraud and Abuse Laws
  • Miscellaneous Federal Laws Related to Pharmacy Practice
  • The Omnibus Budget Reconciliation Act of 1990
• 7. State Regulation of Pharmacy Practice
  • 7. State Regulation of Pharmacy Practice
  • Actions Against a License
  • Actions Against a Pharmacy License
  • Approaches to Regulation
  • Bibliography
  • Case Studies
    • Case 7-1: Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc.
    • Case 7-2: In the Matter of CVS Pharmacy Wayne
    • Case 7-3: In the Matter of Sobel v. Board of Pharmacy
    • Case 7-4: Walgreen Co. v. Selcke
    • Case 7-5: Schram v. Department of Professional Regulation
    • Chapter Slides
  • Licensing
  • Reasons to Regulate Professions
  • Regulation for Outcomes
  • Repository or Take-Back Programs
  • Self-Regulation in Pharmacy
  • Standards of Practice
  • State Boards of Pharmacy
  • State Hospital Pharmacy Licensure Issues
  • State Regulation of Long-Term Care Facilities
  • State Regulation of Third-Party Plans
• 8. Pharmacist Malpractice Liability and Risk Management Strategies
  • 8. Pharmacist Malpractice Liability and Risk Management Strategies
  • Bibliography
  • Case Studies
    • Case 8-1: Happel v. Wal-Mart Stores, Inc.
    • Case 8-2: Hundley v. Rite Aid
    • Case 8-3: Cackowski v. Wal-Mart Stores, Inc.
    • Case 8-4: Nelms v. Walgreen Co.
    • Case 8-5: Van Hattem v. Kmart Corporation
    • Chapter Slides
  • Drug Product Liability
  • Legal Procedure
  • Liability for Failure to Perform Expanded Responsibilities
  • Malpractice Insurance
  • Risk Management Strategies
  • The Malpractice Action
  • The Pharmacist as Risk Manager
• Glossary
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
• Front Matter
  • Preface