A history of nonprescription product regulation
著者
書誌事項
A history of nonprescription product regulation
(Pharmaceutical heritage : pharmaceutical care through history)
Pharmaceutical Products Press, c2003
- : pbk
大学図書館所蔵 全3件
  青森
  岩手
  宮城
  秋田
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  福島
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  静岡
  愛知
  三重
  滋賀
  京都
  大阪
  兵庫
  奈良
  和歌山
  鳥取
  島根
  岡山
  広島
  山口
  徳島
  香川
  愛媛
  高知
  福岡
  佐賀
  長崎
  熊本
  大分
  宮崎
  鹿児島
  沖縄
  韓国
  中国
  タイ
  イギリス
  ドイツ
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  オランダ
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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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