FDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under The Federal Food, Drug, and Cosmetic Act (FDC Act) and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government. It explains the legal framework created by the FDC Act and subsequent statutes, regulations, guidance and policies governing the food and drug industry.
Written by attorneys at Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug law firm in the U.S., FDA Deskbook incorporates more than a century of cumulative experience from positions at FDA, the U.S. Department of Justice, the Drug Enforcement Administration, U.S. Attorney’s Offices, and regulated industry. The result is an essential guidebook, which aims to assist industry stakeholders by providing a wide-ranging review of compliance and enforcement under the FDC Act and related laws.
The book first details the ins-and-outs of FDA’s administrative actions (such as warning letters, import alerts, and recalls) and civil and criminal enforcement authorities. Chapters that follow highlight specific issues affecting the cross-section of FDA regulation:
- Drugs, including OTC, prescription, and compounded drugs, and controlled substances
- Medical devices, including in vitro diagnostic devices
- Food and dietary supplements
- Animal products