This Regulatory Procedures Manual is a reference manual that provides internal procedures and related information to be used by the Food and Drug Administration (FDA) employees who process certain regulatory and enforcement matters in support of the agency's public health mission. The vision of this Manual aims at achieving safe food, safe and effective medical products, and an advanced and protected public health. The mission focuses on: protecting consumers and enhancing public health by maximising compliance of FDA regulated products and minimising risk associated with those products. Chapter 1 provides an overview of the organisational structure of the offices involved in compliance related functions within FDA, and particularly concerns: centre for biologics evaluation and research; centre for drug evaluation and research; centre for devices and radiological health; centre for food safety and applied nutrition; centre for veterinary medicine; centre for tobacco products. Chapter 2 concerns a list of proposed amendments to several Acts and Laws involving Food and Drug Administration competencies. Chapter 3 contains sections on commissioning, information sharing agreements, and information disclosure with other government employees and officials. Chapter 4 concerns the procedures and methods for issuing warning letters, in order to ensure public protection responsibilities of the Agency, and based on the nature of the violation. Chapter 5 concerns administrative actions and detention of food, drugs and devices for adulterated food and drugs, misbranded food and drugs, cosmetics, civil money penalties, order of retention, recall, destruction of manufacturing relating to human cell, tissue, and cellular and tissue-based products.
Chapter 6 concerns judicial actions and focuses on: seizure, injunctions, inspection and search warrants, prosecution, civil penalties, electronic product radiation control. Chapter 7 provides definitions, responsibilities, and procedures for Agency components to initiate, review, classify, publish, audit and terminate recall actions, as methods for removing or correcting marketed products and their labelling. The Chapter focuses on: enforcement report, health hazard evaluation, recall classification process, notification and public warning, monitoring. Chapter 8 concerns emergency procedures for protecting the public from contaminated or defective FDA-regulated products, including significant incidents, such as chemical and biological terrorism, chemical spills affecting food and animal feed supplies, natural disasters, radiological incidents, and food-borne illness outbreaks. The Chapter details: notification of emergency, emergency investigations, operating procedures, interagency coordination. Chapter 9 provides an overview of import procedures for articles subject to the Laws and Regulations enforced by the Food and Drug Administration, and focuses on: importation of biological products; recommendations involving pesticides residues. Chapter 10 concerns other procedures and particularly: inspection of food records; appeal processes.