PHILADELPHIA, PA — Frontage Laboratories, Inc. (Frontage) has agreed to pay $125,000.00 to resolve allegations that it violated the Controlled Substances Act (CSA) by failing to maintain complete and accurate records of controlled substances and failing to keep one controlled substance secured, announced United States Attorney Jacqueline C. Romero on Friday. The United States’ investigation involved Frontage’s facility located at 75 E. Uwchlan Ave., Exton, PA 19341. As part of the settlement, Frontage has entered into a two-year extension of its Memorandum of Agreement (MOA) with the Drug Enforcement Administration (DEA), which includes additional responsibilities regarding the handling of controlled substances. The MOA imposes compliance obligations significantly more stringent than those in the applicable laws and regulations.
Frontage is registered with the DEA as a Manufacturer of schedule I-V controlled substances. Based on an investigation, Frontage entered into a Memorandum of Agreement with the DEA on July 21, 2021. On May 9, 2022, a reinspection was completed on Frontage’s manufacturer registration. The investigators found record-keeping violations, including failure to separate Schedule I-II biennial inventory from Schedule III-V inventory, failure to document the correct amount of certain controlled substances on-hand, failure to record the date and quantity received on four receiving records, record the address and registration number of their own manufacturer and analytical lab on six transfers of controlled substances, and storing one controlled substance in a cabinet, rather than an approved safe.
Frontage acknowledged the seriousness of the issues, corrected the problems, hired new oversight staff, and accepted the extended MOA and the need to pay a penalty.
“Manufacturers who fail to maintain proper records of controlled substances create conditions ripe for diversion,” said U.S. Attorney Romero. “Companies have a responsibility to ensure that all controlled substances are tracked through the distribution chain. Our Office is committed to ensuring total compliance with the Controlled Substances Act, and we will vigorously enforce violations wherever we find them.”
Congress enacted the CSA to deter the illegal importation, manufacture, distribution, possession, and improper use of controlled substances, including prescription medications, and requires individuals and entities registered with the DEA to maintain complete and accurate records of all controlled substances and security systems so that controlled substances are not lost, stolen, or inappropriately dispensed.
The government’s pursuit of this matter demonstrates its commitment to combating diversion of controlled substances. The recordkeeping and other regulations applicable to DEA registrants, including manufacturers, are the tools by which the DEA deters drug diversion.
The investigation was conducted by the DEA’s Philadelphia Field Division, Diversion Regulatory Group 1 and the investigation and settlement was handled by Assistant U.S. Attorney Viveca D. Parker.
The claims resolved by this settlement are allegations only and there has been no determination of liability.
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