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Pharmacy Practice and the Law
Inspections Under the Federal Food, Drug, and Cosmetic Act
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
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P
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Front Matter
Preface
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Inspections Under the Federal Food, Drug, and Cosmetic Act
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