News & Analysis as of

Controlled Substances Act Enforcement Actions

Woods Rogers

Pharmacies and Pharmacists in the Crosshairs: DOJ’s $408 million Settlement with Rite Aid

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Last week, the Department of Justice (DOJ) announced that Rite Aid, ten subsidiaries, and affiliate pharmacies agreed to settle allegations that Rite Aid violated the Controlled Substances Act (CSA) and the False Claims Act...more

Bass, Berry & Sims PLC

Rite Aid and OptumRx Settlements Highlight Enforcement Focus on Pharmacy Corresponding Responsibility for Dispensing Controlled...

Bass, Berry & Sims PLC on

On July 10, the Department of Justice (DOJ) announced a nearly $410 million settlement with Rite Aid Corporation to resolve allegations that Rite Aid and its affiliates ignored red flags and knowingly dispensed unlawful...more

Bass, Berry & Sims PLC

DOJ Releases Annual Civil Fraud Recovery Statistics and Results…A Look Behind the Numbers

Bass, Berry & Sims PLC on

On February 22, the Department of Justice (DOJ) released its annual report of civil fraud recoveries for FY2023, along with a press release highlighting DOJ’s civil enforcement efforts.  Our top ten observations from...more

Bass, Berry & Sims PLC

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

Bass, Berry & Sims PLC on

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

Bass, Berry & Sims PLC

Controlled Substances Act and False Claims Act Collide

Bass, Berry & Sims PLC on

The United States recently intervened in a False Claims Act lawsuit accusing Rite Aid of defrauding federal healthcare programs by seeking reimbursement for opioids the pharmacy allegedly dispensed in violation of the...more

Oberheiden P.C.

SARMs Enforcement and FDA Escalation

Oberheiden P.C. on

Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...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

Mintz - Health Care Viewpoints

Summer 2022: Key Trends in Pharmacy Enforcement Actions

Pharmacies have long been a focus of enforcement actions brought by the Department of Justice (DOJ) and Department of Health and Human Services Office of Inspector General (OIG). This summer has been no exception, with the...more

Epstein Becker & Green

Recent FDA Enforcement Action Colors Regulatory Landscape for Delta-8 THC Products

Epstein Becker & Green on

Much like the ambiguous landscape involving cannabidiol (CBD) products on the consumer market, an influx of delta-8 THC containing products for consumption has highlighted a recurrent regulatory issue surrounding the legality...more

Foley & Lardner LLP

Reading the Leaves: What's in Store for Cannabis in 2021

Foley & Lardner LLP on

On the heels of a year beset by turmoil and the myriad challenges caused by the global pandemic, the cannabis industry nevertheless entered 2021 poised for significant growth amid a landscape teeming with opportunity. Public...more

The Volkov Law Group

DOJ Files Civil Complaint Against Walmart for Illegal Opioid Distribution

The Volkov Law Group on

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

Butler Snow LLP

States’ Efforts to Blunt Federal Criminalization of Marijuana

Butler Snow LLP on

Medical marijuana will be on the ballot this November in Mississippi. Initiative 65 proposes to amend the Mississippi Constitution to allow citizens, certified by physicians, to use medical marijuana. For the most part,...more

Epstein Becker & Green

False Claims Act Enforcement During the COVID-19 Pandemic and Beyond

Epstein Becker & Green on

Earlier this summer, Ethan P. Davis, Principal Deputy Assistant Attorney General for the Civil Division of the U.S. Department of Justice (DOJ) delivered remarks addressing DOJ’s top priorities for enforcement actions related...more

King & Spalding

FDA Releases Progress Report Regarding Enforcement Discretion Policy on Hemp-Derived Cannabidiol (CBD)

King & Spalding on

Last week, FDA submitted a report to Congress detailing the Agency’s progress on developing an enforcement discretion policy (i.e., a policy of not taking enforcement action) on hemp-derived cannabidiol (CBD). At the same...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

Mintz - Health Care Viewpoints

Health Care Enforcement Year-in-Review and 2020 Outlook: Criminal Case Developments

As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the...more

Akin Gump Strauss Hauer & Feld LLP

Podcast: CBD, THC, FDA – What You Need to Know About Cannabis and Its Regulation

In this episode, Akin Gump health care and life sciences partner Howard Sklamberg discusses the history and status of cannabis regulation and enforcement in the U.S., particularly of cannabidiol, or CBD. Among the topics...more

Ward and Smith, P.A.

Beer, Hemp, and CBD in North Carolina

Ward and Smith, P.A. on

The cannabidiol ("CBD") industry is exploding today. Hemp and hemp-derived CBD were classified as Schedule I controlled substances under the Controlled Substances Act of 1972 ("CSA") until the passage of the Agriculture...more

Troutman Pepper

DOJ Files Unprecedented Criminal Charges Against Opioid Distributor and Two Executives

Troutman Pepper on

On April 23, federal prosecutors announced the first-ever felony charges against a drug distributor — Rochester Drug Co-Operative, Inc. (RDC) — and two of its executives for illegally distributing opioid painkillers....more

Burns & Levinson LLP

Jumping the Gun on CBD

Burns & Levinson LLP on

Over the past few months we have posted a number of articles regarding the 2018 Farm Bill and its effective “legalization” of non-psychoactive, cannabis-derived, cannabidiol (“CBD”). While CBD has indeed been removed from...more

McDermott Will & Emery

DOJ Expands New Enforcement Tactic – Obtains TRO to Prevent Pharmacy From Dispensing Opioids

McDermott Will & Emery on

On February 8, 2019, the Department of Justice (DOJ) announced that it obtained a temporary restraining order (TRO) in the Middle District of Tennessee against two pharmacies, their owner and three pharmacists from dispensing...more

Mintz - Health Care Viewpoints

DOJ Updates its Justice Manual to Include Section Limiting Use of Guidance Documents in Litigation

Nearly one year ago, on January 25, 2018, the Department of Justice’s (DOJ) Regulatory Reform Task Force issued a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases.” Many...more

Perkins Coie

What Does the 2018 Farm Bill Mean for the Hemp and CBD Businesses?

Perkins Coie on

President Trump signed the Agriculture Improvement Act of 2018 (popularly known as the 2018 Farm Bill) into law on December 20, 2018. Among the 2018 Farm Bill’s broad-ranging provisions, it legalizes the cultivation and sale...more

Robinson+Cole Health Law Diagnosis

DOJ Enters Into Largest-Ever Civil Settlement with Hospital for Drug Diversion

On May 16, 2018, the U.S. Attorney’s Office for the Southern District of Georgia announced that it had entered into the “largest hospital drug diversion civil penalty settlement in U.S. History” in the amount of $4.1 million...more

Ruder Ware

Recent Fraud Settlements Illustrate Current Compliance Risk Areas

Ruder Ware on

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

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