Richard R.Abood, BS Pharm, JD
Professor Emeritus of Pharmacy Practice
School of Pharmacy and Health Sciences
Thomas J.Long
University of the Pacific, Stockton, California
Kimberly A.Burns, RPh, JD
Professor of Pharmaceutical Sciences, Lake Erie College of Osteopathic Medicine (LECOM) School of Pharmacy, Erie, Pennsylvania; Associate Professor, Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy Pittsburgh, Pennsylvania
Frederick M.Frankhauser,JD, MBA, RPh
Professor, Pharmaceutical Business and Administrative Sciences, Program Director, Regulatory Affairs and Health Policy
School of Pharmacy, Massachusetts College of Pharmacy and Health Sciences (MCPHS), Boston, Massachusetts
Anyone familiar with the Pharmacy Practice and the Law textbook will immediately recognize Richard Abood's name as a coauthor. While he did not directly work on the revision of the 10th edition, I am extremely grateful for the opportunity to have collaborated with him, as well as the mentoring he provided on the past two editions, which has allowed me to continue to revise the textbook moving forward. I am very pleased to welcome Frederick Frankhauser as my coauthor for the 10th edition of Pharmacy Practice and the Law. In this edition, we have continued the effort of previous editions: to provide a resource that is useful for teaching the facts of pharmacy law, providing a degree of depth to support those facts, and stimulating critical thinking about issues in the field. The 10th edition retains the format of the 9th edition while incorporating several of the relevant changes that have recently occurred in pharmacy law.
Some of the changes and updates are the result of suggestions from faculty who use this book as an assigned text in their pharmacy law courses. We appreciate the valuable feedback from those using this book and we hope that we continue to receive this feedback. Although we acknowledge with gratitude the input from many trusted colleagues, we accept full responsibility for any omissions or deficiencies anyone might find in this 10th edition.
This text generally appeals to faculty who believe that a pharmacy law course should be much more than preparation for the board examination. However, as current and longtime pharmacy school faculty members, we also understand the importance of the board examinations, and we collectively reviewed the content covered in the textbook as it relates to the most up to date blueprint for licensure exams. The book also reflects our position that a pharmacy law course should not be just about memorizing laws and regulations and learning the "rules of the game." Rather, the course should prepare students to understand and critically analyze the law that governs both the profession and the products they distribute. Understanding requires that students know some history behind the laws, why they exist, how they affect pharmacy practice, and subsequently, how to apply the law and how to analyze whether there is a better approach. Understanding pharmacy law is critical to understanding the profession. Pharmacy law reflects the history, social policy, and standards of practice that have created and shaped the profession into its current form. Our hope is that this book helps students to understand pharmacy law and, in the process, to develop an awareness and appreciation of the profession they otherwise might not have.
This book contains a great deal of information. Faculty should use their judgment as to how much they expect students to learn. Some might even wish to supplement this text with current articles or additional cases on the various legal topics. The text contains several cites to the Federal Register, Code of Federal Regulations, statutes, public laws, and websites for those wishing to delve deeper into the many topics presented.
The structure of all eight chapters throughout the text remains essentially the same as that of the previous edition except, of course, for the updates. Faculty feedback regarding the take-away points and study scenarios and questions dispersed throughout the text has been very positive; therefore, we have updated and enhanced these resources after the major chapter sections to allow for their continued use as in past editions. Faculty may decide to use the take-away points to highlight key concepts and/or study scenarios and questions to lead class discussions. Furthermore, faculty can refer to the instructor's manual for additional resources, including exercises involving case studies that require students to apply the information read within the text. Faculty also have access to a test bank of multiple-choice questions separated by chapter to incorporate into their course as they consider appropriate.
Cases are included at the end of each chapter because they lead to challenging discussions, stimulate critical thinking, help students learn legal rules better and in greater depth, and kindle student interest. Each case starts with an overview designed to provide a brief explanation of the case and to generally cue the students as to what issues to think about as they read the case. As much as possible, the court's own language has been retained. By doing so, students learn that law is seldom "black and white" but rather requires a considerable measure of reasoning and analysis to reach a decision. Faculty should recognize that the questions raised in the overview are designed to stimulate discussion. A specific correct answer might not always exist; rather, there could be several answers to some of the questions. The notes following each case serve to address the questions arising from the case and to clarify certain points about the case. While numerous colleagues have shared how they do incorporate select cases into their courses, others have shared that they do not. As provided earlier, this book contains a great deal of information, and we encourage faculty to use their judgment in deciding how to best incorporate the content and resources available throughout the book and any of the available resources.
Chapter 1 provides an overview of law and the legal system.
Chapters 2 and 3cover the federal regulation of medications, with Chapter 2 describing the basic regulatory framework of food and drug law and Chapter 3 applying that framework to pharmacy practice.
Chapters 4 and 5 discuss relevant provisions of the federal Controlled Substances Act (CSA). Chapter 4 provides an overview of the framework of the CSA, while Chapter 5 applies that framework more specifically to pharmacy practice.
The main focus of Chapter 6 is the significant influence of the federal government on the state-regulated practice of pharmacy and on business and financial issues related to the profession. From the standards established in the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) to the Medicare and Medicaid laws and the federal antitrust laws, federal requirements for drugs have a profound effect on the professionals who dispense and monitor drugs. This chapter also discusses some very important recent developments involving privacy, electronic records, and pharmacy reimbursement.
Chapter 7 describes some of the basic principles of state regulation of pharmacy practice, including licensure and standard setting. Chapter 7 is intended to provide only a general overview of state law issues and contains a discussion of some important recent regulatory trends occurring among the states and discussions of the similarities and differences among state pharmacy practice acts.
Finally, Chapter 8 provides an overview of malpractice and product liability for order processing and pharmaceutical care activities, with specific tips on liability avoidance through risk management programs. Chapter 8 is important not only to understand legal risk but also to understand the conflicting judicial opinions of the societal expectations of pharmacists, why those expectations exist, and whether they are changing. Courts mirror societal values and sometimes provide us with both flattering and unflattering perspectives of our profession.
Because the overall structure of the text remains the same, faculty who have used this text in the past should not have to make major adjustments in the way they use this new edition.
There have been several legal/regulatory developments that have occurred since the publication of the 9th edition. This 10th edition includes those developments most relevant to the pharmacy profession. A brief chapter-by-chapter description of substantive changes includes:
Changes in Chapter 2 from the previous edition include new or updated discussions of:
PDUFA VII
Food and Drug Omnibus Reform Act (FDORA)
Structure of the Food and Drug Administration
FDA regulation of tobacco and non-tobacco nicotine
Nonprescription drug labeling
Proposal to change (NDC) number from 10- to 12-digit format
FDA public dashboard for medications with an approved REMS
Emergency Use Authorization
Drug Competition Action Plan
Marketed unapproved drugs
Expanded access and right-to-try laws
FDA regulation of software considered as a medical device
OTC hearing aids
Medical devices and the Unique Device Identifier (UDI)
The Modernization of Cosmetics Regulation Act (MCRA) of 2022
Promoting prescription drugs and devices for off-label uses
Changes in Chapter 3 from the previous edition include new or updated discussions of:
Dispensing written, oral, and electronic prescriptions
Labeling requirements (comparing federal, state, and company)
Switch from prescription to OTC: full switch vs partial switch
Nonprescription drug products with additional conditions for use
Emergency contraception (Plan B and the morning after pills)
Conscience clause
Collaborative agreements, statewide protocols, test-to-treat initiatives and immunizations
Drug Quality and Security Act of 2013
Hospital and health system compounding
Insanitary conditions at compounding facilities
Compounding using bulk drug substances
State Memorandum of Understanding (MOU) with FDA
Safe handling of hazardous drugs, including USP 800
Substitution of biosimilar biologics
Purple book transition to searchable database
Drug supply chain security updates including track and trace using electronic data exchange
National licensure standards for wholesale drug distributors and third-party logistic providers
Importation of prescription drugs from Canada
Changes in Chapter 4 include new or updated discussions of the following items:
Classification of controlled substances
Medical and recreational use of marijuana
Schedule III-proposed rules to revoke federal exempted butalbital products
Requirement for all DEA registrants to report suspicious orders
Distributing vs dispensing (constructive delivery)
Applications for DEA registration and reregistration
Modification, transfer, and termination of registration
Expansion of treatment of addicts outside of OTPs
Elimination of the DEA "X" number and patient limits under DATA 2000
Practical considerations with the elimination of the DEA "X" number
Changes in Chapter 5 include new or updated discussions of the following items:
Those allowed to prescribe controlled substances
Issuance of prescriptions
Correcting a written controlled-substance prescription
Purpose of a controlled substance prescription including legitimate medical purpose and the usual course of professional practice
The pharmacists corresponding responsibility and potential legal concerns
The DEA 2022 Pharmacist's Manual
Federal/state efforts to balance pain treatment with the opioid epidemic
Concerns with the 2016 CDC Guidelines leading to the 2022 revisions
CMS requirement for electronic prescribing of schedule II-V prescriptions
Partial filling of schedule II prescriptions under CARA
Pharmacy requirements when making changes to electronic prescriptions
Transfer of controlled substance prescriptions between pharmacies for initial dispensing on a one-time basis
Transferring of prescription information for refill purposes
Return of controlled substances to pharmacy for disposal
Options for hospitals regarding patients admitted with controlled substances
Limited exceptions to telemedicine prescribing of controlled substances without a prior in-person exam
Recent DEA settlements involving pharmacies and recordkeeping violations
Inventory records
Options for prescription files
Options for disposal and destruction of controlled substances
How to address breakage and spillage of controlled substances
Updates to DEA Form 106
Recent DEA enforcement actions against pharmacies
Execution of single-sheet DEA Order Form 222
Distribution of schedule I and schedule II drugs between registrants
Lost and stolen DEA Order Form 222
Changes in Chapter 6 include new or updated discussions of the following items:
Proposed changes regarding the HIPAA privacy rule
Proposed changes under HIPAA regarding a pharmacy's "Notice of Privacy Practices"
Proposed changes regarding improving HIPAA's information sharing for care coordination
Proposed changes regarding HIPAA's right to access provisions
Penalties and enforcement under HIPAA
Health Information Technology infrastructure
Electronic Health Records
Medicare Part D beneficiary costs and enrollment updates
Changes to Medicare Part D under the Inflation Reduction Act of 2022
Insulin prices limited to $35 per month in all Part D plans
Medicare to start negotiating prices of certain drugs in the future
Capping out-of-pocket spending for Part D beneficiaries
Electronic prescribing requirements for Part D plans
MTM updates
Medicare and provider status for pharmacists
Prescription drug coverage under Medicaid
Key pricing terms used by states for reimbursement under Medicaid
Medicaid updates
Medicare/Medicaid fraud and abuse laws
The False Claims Act (FCA)
The Anti-Kickback Statute (AKS)
Compounding pharmacies not protected under certain new safe harbors
Stark law updates
Long-term care unnecessary and psychotropic drugs
Prescription Benefit Managers (PBMs)
340B drugs
Flexible Spending and Health Savings Account Debit Cards
Changes in Chapter 7 include new or updated discussions of the following items:
Licensing of pharmacies
Telepharmacy
Nonresident (Internet) Pharmacies
Grounds for discipline including unprofessional conduct and moral turpitude
Collaborative Practice Agreements, prescriptive authority, and state protocols, including test-to-treat initiatives
Emergency refill authorization
Pandemic response and the impact on standards of practice, including state and federal COVID-19 efforts expanding the role of the pharmacist
Changes in Chapter 8 include new or updated discussions of the following items:
Pharmacists with expanded scope of practice activities
Malpractice insurance
Whether FDA-approved labeling preempts state product liability actions
Strict liability and pharmacists
Study Scenarios and Questions follow each section to enforce the concepts that they have learned.
Take-Away Points highlight the most important information in each section.
Case Studies conclude each chapter and give students real-world examples.
Qualified instructors will receive a full suite of instructor resources, including the following:
More than 250 slides in PowerPoint format
A Test Bank containing questions for each chapter
Instructor's Manual
Answer Key