A history of nonprescription product regulation

著者

• Pray, W. Steven

書誌事項

A history of nonprescription product regulation

W. Steven Pray

（Pharmaceutical heritage : pharmaceutical care through history）

Pharmaceutical Products Press, c2003

• : pbk

注記

Includes index

内容説明・目次

内容説明

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.

目次

Foreword Preface Acknowledgments Chapter 1. Introduction Chapter 2. Early Federal Regulation of Foods and Drugs Regulation Prior to 1800 The 1848 Drug Law The 1886 Butter Fight A Growing Need for Federal Regulation The 1903 Pure Food Law The Push for a 1904 Pure food Law Chapter 3. The Predatory Patent Medicines The Post Office and Patent Medicines Patent Medicine Manufacturers on a Roll Enter the Muckrakers Edward Bok and The Ladies' Home Journal Samuel Hopkins Adams and Collier's Good Housekeeping Magazine Enters the Ring Efforts to Fight Quackery in the Post-Depression Era Did Quackery Ever Die Out? Chapter 4. The 1906 Pure Food and Drugs Act The Jungle Laying the Groundwork for the 1906 Pure Food and Drugs Act The Fifty-Ninth Congress: Victory over Special Interests Dr. Wiley Is Hamstrung by Special Interests The Ill-Fated Coudrey Amendment The Sherley Amendment The 1906 Law and the 1912 Election The Jamaica Ginger Incident Harvey Washington Wiley, "Father of the Food and Drug Law" The FDA: A Capsule History Chapter 5. The Fight Against Baby Killers: The Harrison Narcotic Act of 1914 The "Baby Killers" Public Outcry Becomes Overwhelming The 1914 Harrison Narcotic Act Shortcomings of the Harrison Narcotic Act Charles B. Towns Chapter 6. The 1938 Federal Food, Drug, and Cosmetic Act: Safety Required The Saga of the 1933 Tugwell Bill Copeland's Work on the Tugwell Bill in 1934 Copeland Tries Again in 1935 Copeland Tries Again in 1936 Copeland Continues in 1937 The Plot Thickens: The Lea Bill Is Introduced in the House The Wheeler Bill Adjournment of the 1937 Congress The Advent of Sulfonamides The Elixir of Sulfanilamide Tragedy The 1938 Congress: Action at Last The 1938 Food, Drug, and Cosmetic Act Becomes a Reality A Novel Interpretation of the 1938 Law The 1938 Law and Cosmetics The Supreme Court Broadens the 1938 Law to Include Mailed Advertising FDA Confronts the Atomic Age Chapter 7. Differentiating Prescription Medications from Nonprescription Medications Early FDA Attempts to Control Nonprescription Sales of Dangerous Medications Pharmacists Flaunt the Law California Attempts to Limit Nonpharmacy Sales of Nonprescription Products The Durham-Humphrey Amendment Opposition to the Durham-Humphrey Amendment Who Should Be Able to Sell Nonprescription Products? Further Controls Urged on Barbiturates, Sleepers Chapter 8. The 1962 Kefauver-Harris Amendments: Proof of Effectiveness Trouble for the Drug Manufacturers Thalidomide Thalidomide and the Kefauver Bill Prescription Drug Product Review Begins A Nonprescription Drug Review Is Authorized Chapter 9. The FDA OTC Review and Rx-to-OTC Switching Kefauver-Harris Applied to Nonprescription Medications A Review of Nonprescription Products for Efficacy/Safety Begins The FDA Review and Rx-to-OTC Switches Switching via the "Switch Regulation" Switch Methods Related to the New Drug Application (NDA) Factors Considered in an Rx-to-OTC Switch Decision Chapter 10. Homeopathy The Father of Homeopathy The Doctrines of Homeopathy The Waning of Homeopathy Royal Copeland and Homeopathy FDA Enforcement in Regard to Homeopathics The 1994 FDA Petition and the NABP Homeopathic Popularity Today Lawsuits Challenging Homeopathy Whither Homeopathy? Chapter 11. A History of Dietary Supplement Regulation The Proxmire Amendment to the Food, Drug, and Cosmetic Act The FDA OTC Review in Relation to Vitamins and Minerals The Coincidental Publication Dates L-Tryptophan and Eosinophilia FDA's Reaction to the L-Tryptophan Tragedy The Nutrition Labeling and Education Act The Dietary Supplement Act of 1992 Enactment of the Dietary Supplement Health Education Act of 1994 Contents of the 1994 Dietary Supplement Health and Education Act Post-DSHEA Dietary Supplement Regulation The FDA Modernization Act of 1997 Hijinks on the Internet What Lies in the Future for Dietary Supplements? Notes Index

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詳細情報

• NII書誌ID(NCID): BA65799326
• ISBN:
  • 0789015374
  • 0789015382
• LCCN: 2002012193
• 出版国コード: us
• タイトル言語コード: eng
• 本文言語コード: eng
• 出版地: Binghamton, N.Y.
• ページ数/冊数: xviii, 279 p.
• 大きさ: 23 cm
• 分類:
  • LCC : KF3894.P3
  • DC21 : 344.73/04233
• 件名:
  • LCSH : Drugs, Nonprescription -- Law and legislation -- United States -- History
• 親書誌ID:
  • BA56027515