Fundamentals of Federal Food, Drug, and Cosmetic Act (FD&C Act)

The Fundamentals of the Federal Food, Drug, and Cosmetic Act (FD&C Act) course is designed for professionals seeking to understand this pivotal legislation's core aspects. This course provides a detailed overview of the FD&C Act, covering its history, essential provisions, and impact on regulating food, drugs, cosmetics, and medical devices.

The course explores key provisions, including definitions, prohibited acts, and the FDA’s regulatory authority. Participants will learn about terms like "food," "drug," "cosmetic," and "device," and understand violations related to adulteration and misbranding. The course emphasizes the FDA’s role in enforcement and regulatory oversight.

Significant amendments and updates, such as the Kefauver-Harris Amendments, Medical Device Amendments, and the Food Safety Modernization Act (FSMA), are also covered. Learners will gain insights into how these changes have influenced regulatory practices and current developments affecting the FD&C Act.

Additionally, the course examines the regulation of drugs, food, dietary supplements, and cosmetics, including approval processes and safety requirements. Enforcement mechanisms, including inspections, recalls, and penalties for non-compliance, are reviewed. The course highlights the Act’s impact on industry standards and public health.

By completing this course, participants will develop a solid understanding of the FD&C Act and its enforcement, preparing them to navigate regulatory challenges and contribute to maintaining high safety and efficacy standards.