Somerset County drug manufacturer to pay $2.25 million to settle Controlled Substances Act allegations
SOMERSET COUNTY, NJ – A Somerset County pharmaceutical manufacturer agreed to pay $2.25 million to resolve allegations that it violated the Controlled Substances Act (CSA), according to U.S. Attorney Philip Sellinger.
The manufacturer, Novel Laboratories Inc. (Novel), a subsidiary of Lupin Inc., also reached an administrative resolution with the Drug Enforcement Administration (DEA) by entering into a memorandum of agreement (MOA).
“Manufacturers that work with dangerous and addictive opioids must safeguard the drugs. My office is dedicated to holding every level of the opioid distribution chain accountable for failures to properly handle and account for controlled substances, including manufacturers, distributors, pharmacies, and medical providers to ensure that these drugs are used safely and for legal purposes,” Sellinger said.
“Pharmaceutical companies are not exempt from their regulatory responsibilities especially when dealing with controlled substances and the dangerous effects they have when misused,” Special Agent in Charge Cheryl Ortiz of the Drug Enforcement Administration’s New Jersey Field Division said. “This settlement reflects DEA’s commitment to making sure measures are in place to safeguard the community and hold DEA registrants accountable. I commend our Diversion Investigators for bringing this matter to a resolution”
According to documents filed in this case and the contentions of the United States contained in the settlement agreement, from Jan. 1, 2019, to Aug. 31, 2021, Novel committed CSA violations involving its failure to account for approximately 3.1 kg oxycodone, 7.7 kg hydrocodone, and 30 kg Temazepam.
DEA discovered these violations during on-site inspections of Novel beginning in the summer of 2021. The MOA requires Novel to improve its operations and remain in compliance with the law, and will remain in effect for three years.
“The claims settled by the agreement are allegations only, and there has been no determination of liability,” sellinger said.
