The U.S. life sciences market has specific regulatory challenges outlined by the FDA to protect public health. The U.S. Drug Supply Chain Security Act (DSCSA) defines a system with a timeline for reaching full item traceability by 2023. Each stage requires different levels of compliance by stakeholders. Food and beverages must follow the regulations from the Food Safety Modernization Act (FSMA).
In the United States, the FDA’s Drug Supply Chain Security Act (DSCSA) outlines the steps the pharmaceutical industry needs to take to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
Companies in the food supply must follow the regulations from the Food Safety Modernization Act (FSMA). FSMA enables the FDA to better protect public health by strengthening the food safety system. The law has been enacted after many foodborne illnesses have been reported and have cost the food industry billions of dollars in recalls, lost sales and legal affairs.
