ABSTRACT
Debarment or disqualification of individuals, firms, or Institutional Review Boards presents serious consequences for the people involved as well as the pre-and postmarket approved products. By studying the Generic Drug Enforcement Act of 1992, national and international practitioners, educators, and law and pharmacy students will gain a better understanding of the causes and impact of debarment and what is prohibited and enforced under the Act. This chapter discusses debarment, disqualification, and application compliance and integrity.
