Drugs

Consent Decree Against Drug Distributor

The Puerto Rico federal court has entered a consent decree requiring Droguería Betances LLC (Betances), one of the territory’s largest pharmaceutical distributors, to pay $12 million and make extensive improvements to its compliance program.

According to the Justice Department, the consent decree resolves an 11/3 complaint alleging that from 2016 through at least 6/2019, Betances failed to report to the Drug Enforcement Administration (DEA) hundreds of “suspicious orders” for opioids and other controlled substances distributed to Betances’ pharmacy customers. According to the complaint, this included at least 655 suspicious orders for fentanyl and at least 113 suspicious orders for oxycodone, both of which have contributed to the current opioid abuse epidemic. Betances also committed hundreds of recordkeeping violations, such as filling orders for controlled substances with defective order forms, the government contends.

“Based in part on ability to pay, the consent decree requires Betances to pay $12 million over five years in annual payments, with $10.2 million in the form of civil penalties and $1.8 million in civil forfeiture,” the Justice Department says. “The consent decree also requires Betances to make extensive improvements in its compliance program. Betances must implement improved controlled substance monitoring program procedures and systems to review all orders of controlled substances and to detect and report suspicious orders to DEA. Betances must also improve its procedures and systems for conducting due diligence reviews of its pharmacy customers. The consent decree further requires Betances to submit annual reports about its compliance program and customers to DEA and other Justice Department components.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome