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Abstract
Pharmaceutical quality and consistency has been a focus of pharmaceutical legislation in the United States for well over a century. The first such legislative initiative was the Drug Importation Act of 1848. It was the 1906 Pure Food and Drug Act, however, that first brought the issues of drug safety to the attention of the public. This law was the first to designate the United States Pharmacopeia and National Formulary as standards for quality of drugs prepared in the US. Subsequent legislation and amendments addressed loopholes in this law, but it wasn't until the Food, Drug, and Cosmetic Act was passed in 1938 that fraudulent and misleading claims for pharmaceutical products were addressed. This essay describes each pharmaceutical legislative initiative in the context of pharmacy practice of the time.
Introduction
The year 2006 marks the centennial of the 1906 Pure Food and Drug Act. While frequently considered the first major piece of federal legislation concerned with the purity and safety of medicines, it actually was the third, having been preceded by the Drug Importation Act of 1848 and the Biologies Control Act of 1902. The 1906 legislation captured the attention of the American citizenry, however, in part because of the attention brought to the issue of food safety by Upton Sinclair in his muckraking novel, The Jungle, and by the public media.
Five major national legislative initiatives had a direct impact on pharmacy in the 90-year span beginning with the Drug Importation Act of 1848. The other four were (1) the Biologies Control Act of 1902, (2) the Pure Food and Drug Act of 1906, (3) the Harrison Narcotic Act of 1914, and (4) the Food, Drug, and Cosmetic Act of 1938. Moreover, there were a number of amendments to the various laws, such as the Sherley Amendment of 1912 and the DurhamHumphrey Amendment of 1952. This essay reviews the major federal legislation through focusing on the Drug Importation Act; the Pure Food and Drug Act; and the Food, Drug, and Cosmetic Act; and places the legislation within the context of pharmacy practice of the period. This approach is of particular interest in light of the continuing debate concerning pharmacists' compounding.
Legislation and Regulation
Legislation and regulation are not the same thing,...