Reviewed by: A History of Nonprescription Product Regulation Gwen Kay W. Steven Pray . A History of Nonprescription Product Regulation. Binghamton, N.Y.: Pharmaceutical Products Press (Haworth Press), 2003. xviii + 279 pp. Ill. $59.95 (cloth, 0-7890-1537-4), $39.95 (paperbound, 0-7890-1538-2). If two books on the role of the FDA in regulating food and drugs were published in 2003, one can anticipate a flood for the centennial of the 1906 Pure Food and Drugs Act. Philip Hilts provided an overview of the FDA from the political side of the regulatory process in Protecting the Nation's Health (2003). Now, W. Steven Pray offers a guide to twentieth-century policy regarding drug regulation. This book is comprehensive, albeit with some quirks, and evokes the "big picture" from a pharmacist's perspective. It is clear that nonprescription products are the focus, and Pray examines federal law to explain how nonprescription drugs came to be defined, treated, and regulated. In chronological fashion, he explains the who, what, when, where, and why of food and drug regulation. The book begins with a brief capsule of early regulation, and then charts the battles of the last century, including the 1906 Pure Food and Drugs Act, the 1938 Food, Drug and Cosmetic Act, the 1951 Durham-Humphrey Amendment, and the 1962 Kefauver-Harris Amendments. Because the emphasis is drugs, the 1914 Harrison Amendment Act comes in for a chapter of its own. In many ways, the crux of this book is the 1951 law separating prescription from nonprescription drugs. This law hastened the process by which grocers and five-and-ten-cent stores began selling items formerly found only in drugstores. Subsequent requirements for safety, efficacy, and accurate labeling reassured consumers that nonprescription drugs were not harmful. The availability of nonprescription drugs and related items outside a pharmacy, and drugs "switching" from prescription-only to over-the-counter, means that some pharmacists recommended self-care interventions for conditions that were once not considered to be self-treatable (p. 173). There are some odd leaps and inserts in the book, such as the mini-biographies that appear in only one chapter and are never referred to in the text itself. A chapter on the 1906 law ends with a section on medicine in the atomic age, only to have the following chapter begin in the early 1930s. Major sources are the New York Times and the Congressional Record; papers of the FDA, associations, or participants have not been used. The chapter on homeopathy seems misplaced; if its purpose is to demonstrate the perils of nonprescription items that may be neither efficient nor safe, it appears redundant, in light of the succeeding chapter on dietary-supplement regulation. Because the story on dietary supplements is not yet over, however, the book ends on an odd note, with a one-paragraph conclusion. The target audience seems to be pharmacists, and in this Pray does himself a disservice, because the audience for this book could and should be bigger than that select group. The well-organized layout, almost textbook-like with its headers, short sections, and occasional bullets, lends itself to a broader audience. The book is succinct, yet thorough, in its overview—perhaps not nuanced enough for [End Page 185] historians of the field, but a useful and interesting synthesis for those who do not specialize in food and drug regulatory issues. Gwen Kay State University of New York at Oswego Copyright © 2006 The Johns Hopkins University Press