Guide to Federal Pharmacy Law / Edition 7

Guide to Federal Pharmacy Law / Edition 7

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by Barry S. Reiss, Gary D. Hall

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ISBN-10: 0967633265

ISBN-13: 9780967633268

Pub. Date: 08/28/2010

Publisher: Apothecary Press

This best seller is a comprehensive, easy-to-study guide to current federal pharmacy law that helps you review the most important federal statutes and regulations, including the newest changes in Medicare Part D, Medication Therapy Management (MTM) program guidelines, the Controlled Substance Ordering System (CSOS), new rules for prescribing and dispensing drugs


This best seller is a comprehensive, easy-to-study guide to current federal pharmacy law that helps you review the most important federal statutes and regulations, including the newest changes in Medicare Part D, Medication Therapy Management (MTM) program guidelines, the Controlled Substance Ordering System (CSOS), new rules for prescribing and dispensing drugs that have restricted distribution systems, the Methamphetamine Anti-proliferation Act (MAPA), new HIPAA regulations, the Dietary Supplement Health and Education Act (DSHEA), modified requirements for labeling herbal products, and much more. Designed to assist candidates in preparing for pharmacy law examinations in all states. Also includes over 350 practice federal law questions and answers.

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Apothecary Press
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Table of Contents

Section A 1

Guide to the MPJE® 1

Applying for and Taking the MPJE® 1

Content of the MPJE® 3

MPJE® Competency Statements 4

Tips for Answering MPJE® Questions 7

Common Errors Made By Candidates 11

Section B 13

Sources of Laws, Rules and Regulations 13

Introduction 13

Pure Food and Drug Act of 1906 13

Food, Drug and Cosmetic Act of 1938 14

Durham-Humphrey Amendment of 1951 15

Kefauver-Harris Amendment of 1962 15

Medical Device Amendment of 1976 17

Orphan Drug Act of 1983 17

Drug Price Competition and Patent-Term Restoration Act 17

Prescription Drug Marketing Act of 1987 18

FDA Modernization Act of 1997 19

Medicare Prescription Drug Improvement, and Modernization Act of 2003 20

Official Compendia of the United States 20

Section C 23

Acronyms and Definitions 23

Acronyms 24

Definitions 30

Section D 35

Bringing New Drugs to Market 35

Investigational New Drug Application (IND) 35

Clinical Trials 36

Treatment Investigational New Drugs 37

The New Drug Application (NDA) Process 38

Fast Track Products 39

Abbreviated New Drug Application (ANDA) 39

Supplemental New Drug Application (SNDA) 40

FDA Classification System for New Drugs 40

Orphan Drugs 43

Section E 47

Requirements for Marketed Drug Products 47

Naming New Drugs 47

Patent Protection 48

National Drug Code (NDC) 49

Good Manufacturing Practice (GMP) 51

Adulteration versus Misbranding of Products 51

Product Labeling 53

Labeling Requirements for Manufacturer's Containers 54

Listing of Therapeutically Inactive Ingredients on Labels 55

Special Label Warning Requirements 56

Package Inserts 59

Identification of Commercial Solid DosageForms 61

Prescription Drug Marketing Act 1987 62

Pregnancy Warnings 67

Drugs Subject to Restricted Distribution Programs 68

Off-label Uses of Drugs 73

Unit-dose packaging and labeling 74

Bar Coding of Pharmaceutical Products 76

Customized Patient Med Paks 77

The MedWatch Program 77

Other Product Reporting Initiatives 80

Drug Recalls 81

Prescription Compounding vs. Manufacturing 82

Expiration Dating for Compounded Prescriptions 85

Compounding of Sterile Products for Use in the Home 85

Section F 93

Filling and Dispensing Prescriptions 93

Federal vs. State Regulations 93

Authorization to Prescribe 94

Health Professionals That Self-prescribe 95

Pharmacist's Obligation to Fill a Prescription 95

Prescription Refills 95

Prescription Ownership 96

Prescription File Storage Period 96

Labeling of Prescription Drugs 97

Expiration Dating vs. Beyond Use Dating 98

Poison Prevention Packaging Act (PPPA) 102

Federal Anti-Tampering Act (1982) 108

Patient Package Inserts (PPIs) 111

Medication Guides (MedGuides) 112

Drug Product Substitution 114

Narrow Therapeutic Index Drugs (NTI's) 123

Using the Orange Book 123

Mailing of Prescription Drugs 130

OBRA 90 and Patient Counseling 133

Health Insurance Portability & Accountability Act (HIPAA) 137

International Commerce Involving Drugs and Drug Products 141

Out-of-state and Foreign Prescriptions 142

Section G 151

Controlled Substances 151

Definitions Related to Controlled Substances 151

Registration of Manufacturers, Distributors, and Dispensers 160

Applications for Registration 161

Re-registration 164

Commercial Containers 164

Schedule I Controlled Substances 164

Schedule II Controlled Substances 165

Schedule III Controlled Substances 167

Schedule IV Controlled Substances 170

Schedule V Controlled Substances 172

Excluded (Exempt) Substances 174

Purchasing or Transferring Schedule I or II Substances 175

Completing DEA Form 222 177

Filling Orders Written on DEA Form 222 179

Ordering Controlled Substances Using DEA Form 222 181

Endorsing an Order Form 182

Unaccepted or Defective Order Forms 183

Lost or Stolen Order Forms 184

Storage of Order Forms 185

Return of Unused Order Forms 186

Cancellation and Voiding of Order Forms 186

Controlled Substance Ordering System (CSOS) 187

Compounding or Repackaging With Controlled Substances 194

Persons Entitled To Issue Prescriptions 194

Purpose of Issue of Controlled Substance Prescriptions 195

Issuing Of Controlled Substance Prescriptions 196

Persons Entitled To Fill Controlled Substance Prescriptions 198

Detoxification or Maintenance Treatment 198

Schedule II Prescription Requirements 199

What Is An Emergency? 201

Missing Information 201

Faxing of Schedule II Prescriptions 202

Refilling Schedule II Prescriptions 203

Partial Filling of Schedule II Prescriptions 203

Labeling Schedule II Prescriptions 205

Schedule III, IV, and V Prescription Requirements 207

Refilling of Schedule III, IV or V Prescriptions 208

Partial Filling of Schedule III, IV, and V Prescriptions 214

Labeling and Filling of Schedule III, IV and V Prescriptions 214

Transfer of Prescription Information Between Pharmacies 216

Dispensing Schedule V Controlled Substances Without a Prescription 218

Destruction of Controlled Substances 219

Transfer of Controlled Substances Between Pharmacies 222

Controlled Substance Records 225

Inventory Requirements 228

Verification of DEA Numbers 232

Prescribing by Hospital Employees 233

Mid-level Practitioners (MLP) 234

Storage of Controlled Substances 235

Pharmacy Employment Practices 236

Theft of Controlled Substances 237

Federal Investigation of Pharmaceutical Theft or Robbery 239

Required Records 239

Storing Prescription Information 240

Exportation of Controlled Substances 244

Methamphetamine Anti-Proliferation 245

Section H 251

Treatment of Narcotic Dependence 251

Use of Buprenorphine Products 253

Practitioner Requirements 254

Practitioner Record Keeping Requirements 255

Standards for Federal Opioid Treatment Programs 255

Required Services for OTPs 258

Prevention of Drug Diversion 259

Section I 263

Nonprescription Drugs 263

General Labeling Requirements 263

Dietary Supplement and Nonprescription Drug Consumer Act ("AER") 266

OTC Labeling for Pregnancy and Nursing Mothers 266

OTC Labeling of Sodium Content 267

OTC Labeling for Other Electrolytes 268

Tamper-resistant Packaging 268

Prescription to OTC Reclassification 269

Refilling Prescriptions Written for Nonprescription Drugs 271

Nonprescription Sale of Quinine 272

Section J 273

Dietary and Nutritional Supplements 273

Dietary Supplement Health Education Act (DSHEA) 273

Official Status of Herbals 275

Labeling for Herbals and Dietary Supplements 276

Ban on Sales of Ephedra and Ephedrine Alkaloids 277

Homeopathic Drug Products 279

Section K 281

Cosmetics 281

Section L 285

Miscellaneous Laws and Regulations 285

Alcohol Regulations 285

Americans with Disabilities Act (ADA) 287

E-mail use in Pharmacy Practice 290

Drug-free Workplace 290

Unfair Competition 291

Section M 293

Sample Questions 293

Answers to Sample Questions 365

Section N 367

Index 367

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Guide to Federal Pharmacy Law 5 out of 5 based on 0 ratings. 3 reviews.
Anonymous More than 1 year ago
Guest More than 1 year ago
I bought this book 5 days before I took the MPJE exam in Florida. It's quick reading. No bull. It was a perfect review for the federal law questions on the exam. I aced the exam because of this book.
Guest More than 1 year ago
This book is terrific! It was easy to use and simplified federal law. It helped me pass the MPJE and made Federal Law easy. The questions were right on the money.