What is the primary law governing pharmacy practice in the United States?

The Food, Drug, and Cosmetic Act (FDCA) serves as the primary law governing pharmacy practice in the United States because it encompasses the safety, efficacy, and security of drugs and food products. Established in 1938, the FDCA not only regulates the approval of new pharmaceuticals but also stipulates labeling requirements and sets standards for good manufacturing practices. This law is fundamental in ensuring that medications dispensed by pharmacies meet necessary safety and effectiveness criteria, protecting public health.

The FDCA is broad-ranging in its scope and affects many aspects of pharmacy operations, from how drugs are developed and marketed to how they are dispensed. It provides a framework for the FDA to oversee drug approval processes and monitor drug safety after they are on the market, which is critical for maintaining the integrity of pharmacy practice.

While other laws and regulations, such as the Controlled Substances Act and DEA regulations, are important and specifically address the handling of certain types of medications, they are narrower in focus and serve to supplement the broader guidelines set forth by the FDCA. The Occupational Safety and Health Act pertains primarily to workplace safety rather than directly governing the practice of pharmacy.