The Food Drug and Cosmetic Act (FDCA) is a set of laws passed in 1938 that give authority to the FDA to oversee the safety of drugs, food and cosmetics. This law was passed in response to the death of more than 100 patients due to improper ingredients used in a drug preparation. The FDCA has been expanded over the years to include medical devices and bioterrorism devices.
This three-part lecture will explain how the FDCA protects the public health, identifies the categories of drug products approved for commercial distribution and how drugs are different from the other items regulated by the FDCA. The second and third lectures will cover adulteration and misbranding of drugs as well as the drug approval process and advertising regulations.
Developed & Conducted by the Division of Pharmacy Professional Development, School of Pharmacy, University of Wisconsin-Madison.