US Fines Puerto Rico Drug Firm $12M In Opioid Case

US Fines Puerto Rico Drug Firm $12M In Opioid Case

Introduction

Drogueria Betances, LLC, one of Puerto Rico's major pharmaceutical drug distributors, has been ordered to pay $12 million following allegations of failing to report numerous suspicious orders for controlled substances, as stated by the U.S. Justice Department.

The accusations against the company include not reporting a minimum of 655 orders for fentanyl and at least 113 orders for oxycodone from 2016 through June 2019. These orders were flagged as suspicious due to their frequency and volume, according to the department.

Moreover, Drogueria Betances is also charged with numerous violations related to record-keeping and failing to submit distribution transaction reports to the U.S. Drug Enforcement Administration, particularly concerning opioids, spanning from May 2017 to July 2018.

As part of the settlement, the company has been mandated to enhance its compliance program and promptly report any suspicious orders to the DEA, among other requirements. While Drogueria Betances has agreed to pay the fine and strengthen its reporting system for the distribution of controlled substances, the company has disputed allegations of an inefficient system for monitoring suspicious orders.

In a statement, the company's president highlighted their significant investments in technology and external guidance over the years to ensure strict adherence to the laws and regulations governing controlled medications. The president also clarified that Drogueria Betances has never been accused of diverting controlled products to unauthorized individuals or entities.

This legal action by the U.S. government follows a notable increase in opioid-related fatal overdoses in the U.S. territory of Puerto Rico, with figures rising from 19 deaths in 2017 to 521 in 2021, as per the latest available statistics.