ABSTRACT

From the time the United States Constitution was written in 1787, law has profoundly affected the way pharmacy has been practiced. The first patent laws encouraged and protected drug makers which ushered in the proliferation of unregulated patent medicines. Guided by laissez-faire economic principles, patent medicines flourished under a system that provided few legal safeguards for the public. Though the Drug Importation Act of 1848 was designed to protect the public from faulty imported drugs, it was not until the Pure Food and Drug Act was passed in 1906 that the American public was afforded some protection against harmful drugs. The Food, Drug, and Cosmetic Act of 1938 closed several loopholes in the 1906 law and extended regulation over cosmetics. The Durham Humphrey Amendment in 1951 created two distinct classes of drugs prescription and nonprescription and the Kefauver Harris Amendments in 1962 strengthened previous legislation and gave the FDA greater powers of oversight in ensuring a safe drug supply.