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Puerto Rico Pharmaceutical Distributor Ordered to Pay $12 Million By Federal Court Judgement

Updated: Nov 24, 2023

The Puerto Rico Pharmaceutical Distributor has been directed by the Federal Court to remit a sum of $12 million due to their purported negligence in reporting suspicious orders of pharmaceutical drugs and other violations related to controlled substances.


A consent decree was issued by a federal court in Puerto Rico, mandating Droguería Betances LLC (Betances), one of Puerto Rico's largest distributors of pharmaceutical drugs, to pay $12 million and implement significant enhancements to its compliance program, as announced by the Justice Department today.


The consent decree resolves a complaint filed by the United States on Nov. 3, alleging that Betances failed to report hundreds of "suspicious orders" for opioids and other controlled substances distributed to its pharmacy customers to the Drug Enforcement Administration (DEA) between 2016 and at least June 2019.


These orders were deemed unusual in terms of their frequency, size, or other patterns. The complaint specifically highlights at least 655 suspicious orders for fentanyl and at least 113 suspicious orders for oxycodone, both of which are commonly misused products that have contributed to the ongoing opioid abuse epidemic.


Furthermore, it was alleged in the complaint that between May 2017 and July 2018, Betances failed to fulfill its obligation of reporting distribution transactions to the DEA through an automated reporting system. This includes all of Betances' distributions of Schedule II opioids, which amounted to over 7.8 million dosage units during that time period. The complaint also highlighted numerous recordkeeping violations committed by Betances, such as filling orders for controlled substances with defective order forms and providing inaccurate shipping or delivery information to the DEA.

As stated in the consent decree, the Department of Justice conducted a thorough analysis of Betances' financial condition in relation to the potential civil fines and forfeiture it could face. Taking into account Betances' ability to pay, the consent decree mandates that Betances make annual payments totaling $12 million over a span of five years. Of this amount, $10.2 million will be paid as civil penalties, while $1.8 million will be paid as civil forfeiture.


Additionally, the consent decree imposes significant obligations on Betances to enhance its compliance program. This includes the implementation of improved procedures and systems for monitoring controlled substances, reviewing all orders of controlled substances, and identifying and reporting suspicious orders to the DEA. Betances is also required to enhance its due diligence review processes for its pharmacy customers.


Furthermore, the consent decree stipulates that Betances must submit annual reports to the DEA and other components of the Department of Justice regarding its compliance program and customers. Lastly, Betances must improve its ARCOS reporting system to ensure accurate and proper reporting of all acquisitions and distributions of Schedule II controlled substances.

“Companies that distribute controlled substances to pharmacies and other points of sale have an important responsibility to help stop the illegal distribution of controlled substances by reporting suspicious orders to DEA,” said Principal Deputy Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work with its law enforcement partners to hold accountable those who fail to fulfill their reporting obligations.”


“The duty to report suspicious orders and other reporting requirements imposed on wholesale pharmaceutical distributors by the Controlled Substance Act is critical to ensuring the safety of our citizens from potential harm, including those associated with drug diversion, drug tampering and drug overdoses resulting from illegal drug sales and consumption,” said U.S. Attorney W. Stephen Muldrow for the District of Puerto Rico. “The U.S. Attorney’s Office will continue to do everything in our power to ensure compliance and will use all legal remedies available to hold corporate entities and individuals accountable.”


“As we continue to face unprecedented loss of American lives during the ongoing opioid epidemic, DEA believes that everyone within the pharmaceutical supply chain is responsible for doing their due diligence to prevent the diversion of controlled substances,” said Assistant Administrator Thomas W. Prevoznik of the DEA's Diversion Control Division.


“Compliance with the law is one of the best acts of prevention our registrants can do to ensure that these drugs are distributed for legitimate medical use. Reporting suspicious orders is required under the law and a key part in keeping our communities safe.”


The DEA’s Diversion Control Division, Caribbean Division, San Juan Division Office investigated the case.


Assistant U.S. Attorneys U.S. Attorney and Gabriella S. Paglieri for the District of Puerto Rico and Trial Attorney Tom Rosso of the Civil Division’s Consumer Protection Branch represented the United States.


The claims resolved by the consent decree announced today are allegations only, and there has been no determination of liability.


THANK YOU FOR YOUR TIME





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