US orders Puerto Rico drug distribution company to pay $12 million in opioid case

SAN JUAN, Puerto Rico (AP) — One of Puerto Rico’s biggest distributors of pharmaceutical drugs was ordered to pay $12 million after being accused of not reporting hundreds of suspicious orders for controlled substances, the U.S. Justice Department said Monday.

Drogueria Betances, LLC is accused of not reporting at least 655 orders for fentanyl and at least 113 orders for oxycodone from 2016 through June 2019. The orders were considered suspicious given in part their frequency and size, the department said.

The company also is accused of hundreds of record-keeping violations and of not submitting reports of its distribution transactions to the U.S. Drug Enforcement Administration, including those involving opioids, from May 2017 to July 2018, officials said.

In addition, the company was ordered to improve its compliance program and report suspicious orders to the DEA, among other things.

Drogueria Betances said in a statement that while it agreed to pay the fine and strengthen its system to report the distribution of controlled substances, it rejected allegations that it had an inefficient system to monitor suspect orders.

“Over the past years, we have made million-dollar investments in technology and external advice to ensure strict compliance with the laws and regulations that apply to controlled medications,” Juan Carlos Hernández, the company's president, said in a statement.

He added that Drogueria Betances never was accused of diverting controlled products to unauthorized people or entities.

The complaint filed by the U.S. government comes after the U.S. territory of 3.2 million people reported a surge in deadly overdoses related to opioids, from 19 deaths in 2017 to 521 in 2021, according to the newest available figures.