US Orders Puerto Rico Drug Distribution Company to Pay $12 Million in Opioid Case
Drogueria Betances, one of Puerto Rico's largest pharmaceutical drug distributors, has been ordered to pay $12 million after being accused of failing to report hundreds of suspicious orders for controlled substances, according to the US Justice Department. The company allegedly did not report over 655 orders for fentanyl and at least 113 orders for oxycodone between 2016 and June 2019. These orders were deemed suspicious due to their frequency and size. In addition, Drogueria Betances is accused of record-keeping violations and failure to submit reports of distribution transactions to the US Drug Enforcement Administration, including those involving opioids. The company has been instructed to improve its compliance program and report any suspicious orders to the DEA. While Drogueria Betances agreed to pay the fine and enhance its reporting system, it denies having an inefficient system to monitor suspect orders. The case comes as Puerto Rico has seen a significant increase in opioid-related deaths, with 521 reported in 2021 compared to 19 in 2017.
Implications of the Drogueria Betances Case for New Businesses
The recent ruling against Drogueria Betances, one of Puerto Rico's largest pharmaceutical drug distributors, provides a stark reminder of the importance of regulatory compliance for new businesses, particularly those in the pharmaceutical industry. The company was ordered to pay a hefty $12 million fine for failing to report suspicious orders of controlled substances and for record-keeping violations.
Regulatory Compliance and Reporting
For new businesses, this case underscores the critical need for robust systems to monitor and report transactions, especially those involving controlled substances. The US Drug Enforcement Administration requires businesses to report suspicious orders, and failure to do so can result in significant penalties.
Investing in Compliance Systems
While Drogueria Betances denies having an inefficient system, it has agreed to enhance its reporting system and improve its compliance program. This highlights the importance of investing in technology and external advice to ensure strict compliance with laws and regulations.
In conclusion, new businesses must prioritize regulatory compliance and invest in robust systems to monitor and report transactions. Failure to do so can lead to severe penalties, as demonstrated by the Drogueria Betances case.