On August 23, 2017, United States Attorney Gregory J. Haanstad announced that the United States had settled civil penalty claims against Genco Pharmaceuticals. The company was accused of violating the Controlled Substances Act and its related regulations. Under the terms of the settlement agreement, Genco will pay the United States a civil penalty of $2,000,000.
Genco specialized in the handling, processing and destruction of pharmaceutical returns. The company works with various manufacturers and retail companies throughout the United States. The return processing facility for Genco is located at 6101 North 64th Street in Milwaukee, Wisconsin. Since Genco processes and handles controlled substances, it is obligated to comply with the Controlled Substances Act.
The United States alleged that Genco violated certain regulations starting on January 1, 2012.
- Accused of failing to make, keep and furnish records of all stocks of controlled substances on hand, as well as substances received, sold, delivered, or disposed of.
- Accused of failing to make, keep and furnish complete and precise DEA order forms.
- Accused of failing to provide complete and precise reports to the DEA’s Automation of Reports and Consolidated Orders System Unit.
- Accused of failing to alert the Field Division Office of the DEA in writing of thefts and significant losses of controlled substances within a business day of discovery of theft or loss.
The CSA comes with a civil penalty of up to $10,000 for each violation. Genco has cooperated fully with the DEA’s investigation and has subsequently taken steps to prevent future violations.