ABSTRACT
In 1984, the Hatch-Waxman Amendment of the Federal Food, Drug, and Cosmetic Act was enacted. This amendment, which is also known as the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98^417), allowed lower priced generic drug equivalents of the o¡-patent branded drugs in the United States marketplace. In this chapter, the United States Food and Drug Administration (FDA) requirements governing the stability of generic drugs will be discussed. Stimulated by the growth of the generic industry, a comprehensive journal publication (1) devoted exclusively to the development, manufacturing, quality control, and quality assurance of generic drugs is available in print and on the website.
