"Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act

Abstract

The Food and Drug Administration (hereinafter, FDA) regulates food, drugs, and cosmetics in order to ensure that these products are safe and truthfully labelled. As part of its responsibilities under the Federal Food, Drug, and Cosmetic Act (hereinafter, Act), the FDA monitors the manufacturing practices of companies involved in the production of food, drugs, and medical devices. The manufacturing practices used by these companies must comply with certain standards, identified in the Act as "current good manufacturing practices" (hereinafter, CGMP). If a company's practices do not conform with CGMPs, the finished products are considered adulterated, even if the products are technically perfect. The purpose of CGMPs is to assure the safety and efficacy of the finished products.