Puerto Rico Drug Distributor Penalized $12m for Opioid Violations; Ordered to Improve Compliance Program

Drogueria Betances failed to report hundreds of suspicious orders of fentanyl and oxycodone and record-keeping violations from 2016 to 2019, amid a surge in deadly opioid-related overdoses in Puerto Rico.

• The U.S. Justice Department has ordered Drogueria Betances, a leading pharmaceutical distributor in Puerto Rico, to pay a $12 million fine for failing to report hundreds of suspicious orders, specifically 655 orders of fentanyl and 113 orders of oxycodone from 2016 through June 2019.
• The company is also accused of hundreds of record-keeping violations and not submitting reports of its distribution transactions to the U.S. Drug Enforcement Administration (DEA), including those involving opioids, from May 2017 to July 2018.
• Under the court order, Drogueria Betances is required to make substantial improvements to its compliance program, and to report suspicious orders to the DEA.
• Despite agreeing to pay the fine and strengthen their reporting system, the company denies allegations that it had an inefficient system to monitor suspect orders, stating it has made significant investments in technology and external advice for strict law and regulation compliance.
• This enforcement action follows a sharp increase in opioid-related overdoses in Puerto Rico, with reported deaths rising from 19 in 2017 to 521 in 2021.

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