A History of Nonprescription Product Regulation

A History of Nonprescription Product Regulation
Author: W Steven Pray
Publisher: CRC Press
Total Pages: 306
Release: 2003-07-17
Genre: Medical
ISBN: 9780789015389

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Follow the course of the battle to protect American consumers from unsafe and ineffective nonprescription pharmaceutical products! A History of Nonprescription Product Regulation explores the regulation of nonprescription products in the United States via an examination of the circumstances surrounding the passage of various laws. It untangles the process by which those bills became law, beginning with early federal regulations and moving through the laws that were passed in 1906 and 1938 and the amendments that came in 1951 and 1962. It relates important issues of the day (muckraking, sulfanilamide, thalidomide) to those laws by carefully describing their influence on pending legislation. In its coverage of the laws that govern nonprescription products, A History of Nonprescription Product Regulation makes extensive use of widely varied source material that gives the book a contemporary tone that is quite unique in texts of this kind. For instance, the reader wishing to more fully understand the 1906 Pure Food and Drug Act will be treated to a view of that act drawn from the pages of The New York Times, the Congressional Record, and various journals that were published while the act was being debated. In A History of Nonprescription Product Regulation, you will find clearly written chapters covering: how prescription medications differ from nonprescription products early food and drug regulations established by the federal government patent medicines the Pure Food and Drug Law of 1906 the Harrison Narcotic Act of 1914 the federal Food, Drug, and Cosmetic Act of 1938 the Kefauver-Harris Amendments of 1962 Rx-to-OTC switching and the FDA's review of over-the-counter products regulations relating to homeopathy and dietary supplements Well-referenced and richly complemented with dozens of photographs, this essential volume illuminates the struggle—on many fronts—to achieve a situation in which the American consumer can purchase safe and effective nonprescription products.

Nonprescription Product Therapeutics

Nonprescription Product Therapeutics
Author: W. Steven Pray
Publisher: Lippincott Williams & Wilkins
Total Pages: 974
Release: 2006
Genre: Medical
ISBN: 9780781734981

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When it comes to helping customers make wiser and safer choices in their use of over-the-counter treatments, the pharmacist's best source of information is Nonprescription Product Therapeutics. This text emphasizes the pharmacist's role in triage--assessing the best nonprescription products for a client and knowing when medical conditions warrant a referral to another health professional. Organized by condition rather than by drug, the text is easy to consult, and complements a disease-based approach to therapeutics. Pharmacists will find useful information on ingredients, interactions, contraindications, and other essentials for helping customers choose appropriate nonprescription products. The Second Edition contains additional charts, drawings, illustrations, and tables. The book includes decision-making algorithms, case studies, patient counseling tips, and warnings on dangerous or life-threatening ingredients, actions, or situations. Another unique feature of this text is A Pharmacist's Journal--real-life reports from the front lines by an award-winning professor and researcher with over twenty years of experience in retail community pharmacy.

Taking Your Medicine

Taking Your Medicine
Author: Peter Temin
Publisher:
Total Pages: 296
Release: 1980
Genre: Business & Economics
ISBN:

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A history of the federal regulation of the sale and use of medicinal drugs throughout the twentieth century examines the reasons for and impact of Federal Food and Drug Administration.

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
Author: Eunjoo Pacifici
Publisher: Academic Press
Total Pages: 292
Release: 2018-06-13
Genre: Medical
ISBN: 0128111569

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Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

A History of Public Health

A History of Public Health
Author: George Rosen
Publisher: JHU Press
Total Pages: 441
Release: 2015-04-01
Genre: Medical
ISBN: 1421416026

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George Rosen's wide-ranging account of public health's long and fascinating history is an indispensable classic. Since publication in 1958, George Rosen's classic book has been regarded as the essential international history of public health. Describing the development of public health in classical Greece, imperial Rome, England, Europe, the United States, and elsewhere, Rosen illuminates the lives and contributions of the field's great figures. He considers such community health problems as infectious disease, water supply and sewage disposal, maternal and child health, nutrition, and occupational disease and injury. And he assesses the public health landscape of health education, public health administration, epidemiological theory, communicable disease control, medical care, statistics, public policy, and medical geography. Rosen, writing in the 1950s, may have had good reason to believe that infectious diseases would soon be conquered. But as Dr. Pascal James Imperato writes in the new foreword to this edition, infectious disease remains a grave threat. Globalization, antibiotic resistance, and the emergence of new pathogens and the reemergence of old ones, have returned public health efforts to the basics: preventing and controlling chronic and communicable diseases and shoring up public health infrastructures that provide potable water, sewage disposal, sanitary environments, and safe food and drug supplies to populations around the globe. A revised introduction by Elizabeth Fee frames the book within the context of the historiography of public health past, present, and future, and an updated bibliography by Edward T. Morman includes significant books on public health history published between 1958 and 2014. For seasoned professionals as well as students, A History of Public Health is visionary and essential reading.

A Brief History of Pharmacy

A Brief History of Pharmacy
Author: Bob Zebroski
Publisher: Routledge
Total Pages: 261
Release: 2015-08-20
Genre: History
ISBN: 1317413334

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Pharmacy has become an integral part of our lives. Nearly half of all 300 million Americans take at least one prescription drug daily, accounting for $250 billion per year in sales in the US alone. And this number doesn't even include the over-the-counter medications or health aids that are taken. How did this practice become such an essential part of our lives and our health? A Brief History of Pharmacy: Humanity's Search for Wellness aims to answer that question. As this short overview of the practice shows, the search for well-being through the ingestion or application of natural products and artificially derived compounds is as old as humanity itself. From the Mesopotamians to the corner drug store, Bob Zebroski describes how treatments were sought, highlights some of the main victories of each time period, and shows how we came to be people who rely on drugs to feel better, to live longer, and look younger. This accessible survey of pharmaceutical history is essential reading for all students of pharmacy.

Medical Devices and the Public's Health

Medical Devices and the Public's Health
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 318
Release: 2011-10-25
Genre: Medical
ISBN: 0309212456

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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Quack Medicine

Quack Medicine
Author: Eric W. Boyle
Publisher: Bloomsbury Publishing USA
Total Pages: 265
Release: 2013-01-09
Genre: Health & Fitness
ISBN: 0313385688

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This timely volume illustrates how and why the fight against quackery in modern America has largely failed, laying the blame on an unlikely confluence of scientific advances, regulatory reforms, changes in the medical profession, and the politics of consumption. Throughout the 20th century, anti-quackery crusaders investigated, exposed, and attempted to regulate allegedly fraudulent therapeutic approaches to health and healing under the banner of consumer protection and a commitment to medical science. Quack Medicine: A History of Combating Health Fraud in Twentieth-Century America reveals how efforts to establish an exact border between quackery and legitimate therapeutic practices and medications have largely failed, and details the reasons for this failure. Digging beneath the surface, the book uncovers the history of allegedly fraudulent therapies including pain medications, obesity and asthma cures, gastrointestinal remedies, virility treatments, and panaceas for diseases such as arthritis, asthma, diabetes, and HIV/AIDS. It shows how efforts to combat alleged medical quackery have been connected to broader debates among medical professionals, scientists, legislators, businesses, and consumers, and it exposes the competing professional, economic, and political priorities that have encouraged the drawing of arbitrary, vaguely defined boundaries between good medicine and "quack medicine."

A Social History of Medicines in the Twentieth Century

A Social History of Medicines in the Twentieth Century
Author: John Crellin
Publisher: CRC Press
Total Pages: 362
Release: 2004-04-22
Genre: Medical
ISBN: 9780789018458

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Get a fresh perspective on the day-to-day use of medicine! A Social History of Medicines in the Twentieth Century explores the most perplexing issues concerning the uses of prescriptions and other medicines on both sides of the Atlantic. The book equips you with a thorough understanding of the everyday use of medicine in the United States, Canada, and Britain, concentrating on its recent past. Dr. John K. Crellin, author of several influential books on the history of medicine and pharmacy, addresses vital topics such as: the emergence of prescription-only medicines; gate-keeping roles for pharmacists; the role of the drugstore; and the rise of alternative medicines. A Social History of Medicines in the Twentieth Century adds the historical perspective missing from most medical and pharmaceutical literature about trends in the day-to-day use of medicines in society. The book is essential reading for anyone taking regular medication, either as self-care or by a physician’s prescription. Topics discussed include the non-scientific factors that validate medicines, the relevance of the control of narcotics, marketing strategies used by the pharmaceutical industry, the changing authority of physicians and pharmacists, over-the-counter medicines, tonics and sedatives, and patient compliance—and non-compliance. A Social History of Medicines in the Twentieth Century also addresses: medicines for weakness (“health” foods, fortifiers, digestives/laxatives) poison and pharmacy legislation placebos tranquilizers and antidepressants hormones side-effects psychoactive medications herbal medicines a brief history of the use of medicines from the 17th to 19th centuries suggestions for future policies and much more! A Social History of Medicines in the Twentieth Century is equally vital as a professional resource for physicians, pharmacists, and health care administrators, as a classroom guide for academics working in the medical and pharmaceutical fields, and as a resource for patients.