Pharmacy Practice and the Law

Univ. of the Pacific, Stockton, CA. Second author, David B. Brushwood, is with Univ. of Florida, Gainesville. Textbook, for pharmacy students, features key case studies, updated material covering new regulations and changes in practice, and revised content to correspond with recent directives launched by the American Association of Colleges of Pharmacy. Prev. ed: c1997. Softcover.

Preface

ix

The Law and the Legal System

1

(36)

Chapter Objectives

1

(1)

Nature and Role of Law

2

(3)

Sources of United States Law

5

(6)

The Legislative Process

11

(2)

Distinguishing Criminal, Civil, and Administrative Law

13

(1)

The Judicial Process

13

(7)

Case Studies

20

(17)

Federal Regulation of Medications: Development, Production, and Marketing

37

(65)

Chapter Objectives

37

(1)

Historical Overview of the Federal Food, Drug and Cosmetic Act

37

(6)

Defining and Distinguishing Drugs from Foods, Devices, and Cosmetics

43

(8)

Prohibited Acts, Penalties, and Enforcement

51

(3)

Adulterated Drugs

54

(2)

Misbranded Drugs

56

(7)

New Drug Approval

63

(5)

Generic Drugs as New Drugs

68

(3)

Drugs Intended To Treat Serious and Life-Threatening Diseases

71

(1)

Voluntary Reporting Programs

72

(1)

Medical Device Act (Amendments) of 1976

73

(1)

Cosmetics

74

(1)

Drug Advertising and Promotion

75

(8)

Case Studies

83

(19)

Federal Regulation of Medications: Dispensing

102

(47)

Chapter Objectives

102

(1)

Durham-Humphrey Amendment

103

(9)

Approved Drugs for Unlabeled Indications

112

(1)

Pharmacy Compounding versus Manufacturing

113

(5)

The ``Orange Book''

118

(2)

Prescription Drug Marketing Act of 1987

120

(3)

Inspections under the Federal Food, Drug and Cosmetic Act

123

(1)

Federal Alcohol Taxation

123

(1)

Poison Prevention Packaging Act

124

(2)

Drug Advertising by Pharmacies

126

(4)

Case Studies

130

(19)

The Closed System of Controlled Substance Distribution

149

(39)

Chapter Objectives

149

(1)

State versus Federal Authority

150

(1)

Classification of Controlled Substances

151

(2)

Authority for Scheduling

153

(1)

Manufacturer Labeling and Packaging

154

(1)

Registration

154

(8)

Security Requirements

162

(1)

Penalties

163

(2)

Inspections under the Controlled Substances Act

165

(4)

Narcotic Treatment Programs

169

(1)

Laws Related to the Controlled Substances Act

170

(2)

Case Studies

172

(16)

Dispensing Controlled Substances

188

(50)

Chapter Objectives

188

(1)

Prescriptions

188

(15)

Recordkeeping

203

(11)

Drug Enforcement Administration Order Form 222

214

(5)

Case Studies

219

(19)

Federal Regulation of Pharmacy Practice

238

(42)

Chapter Objectives

238

(1)

The Omnibus Budget Reconciliation Act of 1990

239

(6)

Medicare

245

(3)

Medicaid

248

(3)

Federal Regulation of Long-Term Care

251

(3)

Federal Antitrust Laws

254

(10)

Medicare/Medicaid Fraud and Abuse Statute

264

(1)

Safe Harbor Regulations

264

(1)

Case Studies

265

(15)

State Regulation of Pharmacy Practice

280

(39)

Chapter Objectives

280

(1)

Self-Regulation in Pharmacy

280

(1)

A Different World

281

(1)

Approaches to Regulation

281

(2)

State Board of Pharmacy

283

(1)

Licensing

284

(2)

Actions against a License

286

(4)

Standards of Practice

290

(3)

State Hospital Pharmacy Licensure Issues

293

(2)

State Regulation of Long-Term Care

295

(1)

State Legislative Efforts To Regulate Third-Party Plans

296

(2)

Regulation for Outcomes

298

(2)

Case Studies

300

(19)

Pharmacist Malpractice Liability and Risk Management Strategies

319

(48)

Chapter Objectives

319

(1)

Legal Procedure

320

(1)

The Malpractice Action

320

(8)

Liability for Failure To Perform Expanded Responsibilities

328

(8)

Risk Management Strategies

336

(5)

The Pharmacist as Risk Manager

341

(3)

Malpractice Insurance

344

(1)

Case Studies

345

(22)

Table of Cases

367

(4)

Index

371

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Pharmacy Practice and the Law

Summary

Table of Contents

Supplemental Materials