News & Analysis as of

Controlled Substances Act Pharmaceutical Industry Controlled Substances

McDermott+

Pending DEA Extension on Prescription of Controlled Substances via Telemedicine

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A new rule posted on the Office of Management and Budget (OMB) registry suggests that the Drug Enforcement Administration (DEA) is planning an additional extension of COVID-19 flexibilities for telemedicine prescribing of...more

Morgan Lewis - As Prescribed

Taking a Trip into the Future of Psychedelics

The development of psychedelic drugs for medicinal uses has substantially expanded since 2020, as evidenced by an exponential growth in Drug Enforcement Administration (DEA) production quotas for both psilocybin and psilocin....more

Nelson Hardiman, LLP

Too Much Of A Good Thing?

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F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more

Mandelbaum Barrett PC

Life on the Line: Battling Bureaucracy for Timely Medical Innovations

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In the ever-evolving landscape of medical innovation, the journey to bring breakthrough therapies to those in need is often fraught with obstacles and red tape. For many patients grappling with life-threatening conditions,...more

Quarles & Brady LLP

Protect Your CSOS Credentials…Or Else.

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Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to electronically transmit controlled substance orders) and Electronic Prescriptions for Controlled...more

Bass, Berry & Sims PLC

DEA Releases Updated Practitioner’s Manual for Registrants Handling Controlled Substances

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On June 14, the Drug Enforcement Administration (DEA) released an updated Practitioner’s Manual, the first new version of the manual since 2006. The Practitioner’s Manual provides guidance for all DEA registrants handling...more

Sheppard Mullin Richter & Hampton LLP

DEA Proposes Rule for Post-PHE Telemedicine

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008...more

Robinson+Cole Health Law Diagnosis

As COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances

On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth...more

Manatt, Phelps & Phillips, LLP

DEA Releases Proposed Rules Regarding Telemedicine Prescribing of Controlled Substances

The Big Picture - On February 24, the Drug Enforcement Administration (DEA), in consultation with the Department of Health and Human Services (HHS), issued two proposed rules that address the prescribing of controlled...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

Oberheiden P.C.

U.S. Supreme Court Overturns Doctors’ Opioid Convictions in Ruan v. United States, Paving the Way for Additional Appeals

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On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United...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

McGuireWoods LLP

Pain Management or Pill Mill? Supreme Court to Weigh in on Standards for Prosecutions of Practitioners Prescribing Narcotics

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Introduction - Next week, the Supreme Court will hear oral argument in a pair of cases that may reshape the landscape of legitimate prescribing under the Controlled Substances Act (“CSA” or “the Act”). In companion cases...more

Oberheiden P.C.

DOJ Opioid Enforcement Defense

Oberheiden P.C. on

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

Arnall Golden Gregory LLP

Hello, Teleph(armacy) Line: DEA Seeks Public Comment Concerning Telepharmacy Regulation

With a nod to the Electric Light Orchestra’s 1976 song, “Telephone Line,” the Drug Enforcement Administration (“DEA”) issued an Advanced Notice of Proposed Rulemaking (“ANPR”) regarding the practice of telepharmacy. The...more

Fox Rothschild LLP

Psychedelics Take A Long, Strange Trip Back To Mainstream Research

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With the ever-increasing acceptance of marijuana as a legitimate treatment for a number of medical conditions, a newfound interest in the use of psychedelics as a form of medical treatment is gaining traction once again. ...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

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

Oberheiden P.C. on

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

Harris Beach PLLC

Partial Summary Judgment Win for Major Pharmacy Chains in New York Litigation Deemed "Essential"

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The pharmacy defendants – major national corporations CVS Pharmacy, Inc., Rite Aid of Maryland, Inc., Walgreen Co., and Walmart Inc., sued by Long Island counties Nassau and Suffolk (County Plaintiffs) in their capacities as...more

Buchalter

Buchalter Client Alert COVID-19: Requirements on Telehealth Prescriptions Eased for COVID-19

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The Drug Enforcement Administration (“DEA”) has waived the in-person examination requirement for prescribing controlled substances via telemedicine in the wake of COVID-19, relaxing the prescribing requirements under the...more

Foley & Lardner LLP

COVID-19: DEA Confirms Public Health Emergency Exception for Telemedicine Prescribing of Controlled Substances

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With the rapid spread of the novel coronavirus (COVID-19) pandemic and the looming possibility of large scale isolations and quarantines, lawmakers continue to demonstrate willingness to expand access to telehealth to combat...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

McDermott Will & Emery

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

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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

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