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Controlled Substances Act Opioid DEA

ArentFox Schiff

Investigations Newsletter: DOJ Launches Corporate Whistleblower Awards Pilot Program

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DOJ Launches Corporate Whistleblower Awards Pilot Program - On August 1, the US Department of Justice (DOJ) announced the details of its new Corporate Whistleblower Awards Pilot Program. According to the DOJ, the...more

Console and Associates, P.C.

Parents Bring Kratom Lawsuits Following Overdose Deaths and Other Serious Injuries

Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more

Bass, Berry & Sims PLC

DEA Reaches $19 Million Administrative Settlement for Controlled Substances Act Violations

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On February 7, the U.S. Drug Enforcement Administration (DEA) announced that it has entered into a settlement requiring opioid distributor Morris & Dickson Co. to forfeit $19 million to resolve a years-long administrative...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - March 14th - 15th, Washington, DC

Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more

Quarles & Brady LLP

High Court Rules “State of Mind” Relevant in Prosecuting Prescribers under the Controlled Substance Act

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Last week the Supreme Court ("the Court") released a decision holding that the Federal Controlled Substance Act (the "Act") provision that criminalizes the dispensing of a controlled substance “except as authorized” includes...more

Fox Rothschild LLP

Enhanced Scrutiny of Opioid Prescriptions Poses Legal Risks for Medical Professionals

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The U.S. Department of Justice recently charged multiple physicians and health care professionals for opioid-related crimes in a crackdown with a clear message to individuals in the industry: If you are involved with...more

Jackson Lewis P.C.

Drug Overdoses in 2021 at Highest Level on Record According to CDC, Driven By Opioids

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The Centers for Disease Control and Prevention (CDC) published data on May 11, 2022 concluding that drug overdoses in 2021 reached the highest levels on record. CDC stated that an estimated 107,622 drug overdose deaths...more

Oberheiden P.C.

DOJ Opioid Enforcement Defense

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The Controlled Substances Act (“CSA”) - The CSA (21 U.S.C. 801 et seq.) imposes a framework that regulates different categories of certain drugs that pose dependency and abuse risks to the public. The CSA applies only to...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

The Volkov Law Group

DOJ Files Civil Complaint Against Walmart for Illegal Opioid Distribution

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The Justice Department handed Walmart a huge slap in the face last year with the filing of a comprehensive civil case alleging that Walmart knowingly distributed large quantities of opioids in disregard of the law that fueled...more

Mintz - Health Care Viewpoints

DEA Releases Long-Awaited Suspicious Orders Proposed Rule

It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more

Oberheiden P.C.

DEA Compliance for 2021 - How the DEA’s 2021 Proposed Aggregate Production Quotas Affect Pharmaceutical Companies and Society

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The DEA struggles to balance the pressing need to provide pain relief for those suffering from the novel coronavirus with the ongoing effort to reduce the opioid epidemic in the United States. I. Overview on the DEA and the...more

Epstein Becker & Green

Deadline Looms for Responding to DEA’s Proposed Aggregate Production Quotas for 2021

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On Tuesday, September 1, 2020, the Drug Enforcement Agency (“DEA”) proposed 2021 aggregate production quotas (APQs) for controlled substances in schedules I and II of the Controlled Substances Act (“CSA”) and an Assessment of...more

Foley & Lardner LLP

Telehealth and Substance Use Disorder Treatment: Regulatory Barriers to Entry Can Mean Opportunity for Innovative Companies

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...As COVID-19 cases spread across the U.S., another public health issue continues to escalate: the rise of opioid-related overdose deaths. For patients with a substance use disorder (SUD), the pandemic has increased feelings...more

Foley & Lardner LLP

COVID-19: DEA and SAMHSA Guidance for Treating Opioid Use Disorders via Telehealth

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As the world fights to contain the spread of the novel Coronavirus (COVID-19), the U.S. continues to combat another domestic public health issue: the opioid epidemic, the crisis created by prescription and illicit opioid...more

Kramer Levin Naftalis & Frankel LLP

Delaware Chancery Court Holds That Stockholders Had a “Proper Purpose” to Seek Board Materials From Opioid Distributor, and Orders...

In a 63-page decision issued on Jan. 13, 2020, in Lebanon County Employees’ Retirement Fund v. AmerisourceBergen Corporation, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery found that stockholders of...more

Harris Beach PLLC

Two Executives and Distributor Charged for Unlawfully Distributing Controlled Substances

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Rochester Drug Co-Operative, Inc. (“RDC”), one of the 10 largest pharmaceutical distributors in the United States, was recently charged along with its former Chief Executive Officer and former Chief Compliance Officer, for...more

King & Spalding

Court Grants TRO Requested by DOJ to Shut Down Pharmacies Accused of Controlled Substances Act Violations

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On Thursday, February 7, 2019, the U.S. District Court for the Middle District of Tennessee granted a request by the Department of Justice (DOJ) for a temporary restraining order (TRO) to close two pharmacies accused of...more

Ruder Ware

Recent Fraud Settlements Illustrate Current Compliance Risk Areas

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One of the reasons compliance officers and health care attorneys read fraud settlements is to identify issues the government is focused on. The cases the government decides to pursue are very indicative of the areas of fraud...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic: Federal and State Requirements on Medication-Assisted Treatment for Substance Abuse...

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In the sixth episode of our series on the national opioid crisis, Lauren Perry discusses some of the legal obligations for providers who prescribe controlled substances as treatment for substance abuse disorders....more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic: DEA’s Role in Regulating Individuals and Entities Handling Controlled Substances

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In the fifth episode of our series on the national opioid crisis, Hilary Bowman discusses the Drug Enforcement Administration’s (DEA) role in regulating individuals and entities handling controlled substances, including...more

Kilpatrick

Will Kratom Be Restricted?

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Kratom, a popular alternative medicine used as a home remedy for opioid addiction, is now classified by the Food and Drug Administration (“FDA”) as an opioid – a step that may lead to the classification of the substance as a...more

McDermott Will & Emery

Congress and Obama Administration Take Steps to Ease Buprenorphine Access

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On Friday, July 22, President Obama signed the Comprehensive Addiction and Recovery Act of 2016 (CARA). Following on federal, state and local trends, CARA seeks to expand access for persons needing opioid treatment....more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

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