Pharmaceutical legislation: an historical perspective

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 pharaceutical products were addressed. This essay describes each pharmaceutical legislative initiative in the context of pharmacy practice of the time.