News & Analysis as of

Prescription Drugs Controlled Substances Act

Oberheiden P.C.

4 Things to Know About Ketamine Investigations

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Federal law enforcement agencies, including the U.S. Drug Enforcement Administration (DEA), have amped up their investigations into the drug ketamine in recent years, likely in reaction to some high-profile overdose deaths....more

Epstein Becker & Green

The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care

Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to...more

ArentFox Schiff

Investigations Newsletter: DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to...

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DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more

Axinn, Veltrop & Harkrider LLP

Thankful for Pharmaceuticals . . . Especially When There are Shortages

5 When our children were young, we started a tradition at Thanksgiving of going around the table and having each of us (around 20 with extended family) saying what we were thankful for. Of course, you hear a lot of being...more

Quarles & Brady LLP

Protect Your CSOS Credentials…Or Else.

Quarles & Brady LLP on

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

Holland & Knight LLP

New DEA Rule Allows Single Electronic Transfer of Controlled Substance Prescriptions

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Historically, a retail pharmacy unable to fill an initial electronic prescription for Schedule II-V controlled substances could not transfer it to another pharmacy – even if the two pharmacies were affiliated and part of a...more

Foley & Lardner LLP

DEA: Potential New Telemedicine Special Registration for Controlled Substances Prescribing to be Discussed in Special Listening...

Foley & Lardner LLP on

At long last, the Drug Enforcement Administration (DEA) has signaled its consideration of a separate Special Registration for telemedicine prescribing for patients without requiring an in-person examination. On August 4,...more

Epstein Becker & Green

DEA to Host Listening Sessions on Remote Prescribing

On August 4, 2023, the Drug Enforcement Administration (“DEA”) announced plans to host two public listening sessions, scheduled to take place on September 12 and 13, 2023 at DEA’s headquarters in Arlington, VA, to collect...more

Foley & Lardner LLP

Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

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On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more

Gardner Law

FDA Publishes First Draft Guidance for Clinical Trials with Psychedelic Drugs

Gardner Law on

Lastly, there are several clinical factors the Agency encourages sponsors to consider. One way psychedelics differ from other drugs is that the use of a traditional placebo as a control may be challenging, as an active drug...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

Holland & Knight LLP

FDA Issues First Guidance on Clinical Trials for Psychedelic Drugs

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The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more

McGlinchey Stafford

CBD & The Workplace, A Word to The Wise

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Federally legal CBD products may, under some circumstances, cause consumers to fail drug tests. An employer’s right to terminate employee-consumers on that basis is not prohibited by federal law, including the Americans with...more

Goodwin

DEA Publishes Temporary Rule on the Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances

Goodwin on

Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...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

Foley & Lardner LLP

DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications

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On May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of...more

Goodwin

DEA Proposes Rules to Allow Prescribing Controlled Substances via Telemedicine, Subject to Significant Limitations

Goodwin on

Less than one month after the Biden administration’s announcement on January 20, 2023, declaring the end of the public health emergency (PHE) on May 11, 2023, the US Drug Enforcement Administration (DEA) has announced...more

Hendershot Cowart P.C.

DEA Proposes Rules for Permanent Pandemic Telehealth Flexibilities

Hendershot Cowart P.C. on

Meta description: With the federal public health emergency (PHE) ending in May, changes to telehealth prescription rules are set to change. Read on to learn about proposed permanent changes. DEA Proposes Rules for...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

Holland & Knight LLP

DEA Proposes New Telehealth Prescribing Rules

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The COVID-19 public health emergency (PHE) is set to expire on May 11, 2023, and there seems to be a scramble to extend some of the pandemic-related flexibilities involving telehealth. On March 1, 2023, the Drug Enforcement...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

King & Spalding

DEA Proposes New Rules for Telemedicine Prescriptions

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Would Require In-Person Examination In Many Prescribing Scenarios - Almost fifteen years ago, Congress amended the Controlled Substances Act (CSA) to reduce illegitimate, Internet-based access to controlled drugs while, at...more

McDermott Will & Emery

DEA Proposes Limited Post-PHE Telemedicine Prescription of Controlled Substances

On February 24, 2023, the US Drug Enforcement Administration (DEA) issued two proposed rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule) that would establish...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

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