A History of Nonprescription Product Regulation

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CRC Press, Jul 17, 2003 - Medical - 279 pages
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.

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Early Federal Regulation of Foods and Drugs
The 1906 Pure Food and Drugs Act
The 1938 Federal Food Drug and Cosmetic
Copelands Work on the Tugwell Bill in 1934
Copeland Tries Again in 1936
The Elixir of Sulfanilamide Tragedy
Action at Last
A Novel Interpretation of the 1938 Law
Differentiating Prescription Medications
Opposition to the DurhamHumphrey Amendment
The FDA OTC Review and RxtoOTC
A History of Dietary Supplement Regulation

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