News & Analysis as of

Controlled Substances Pharmaceutical Industry Prescription Drugs

Kelley Drye & Warren LLP

Highlights from the 2025 NAAG Presidential Summit

In early August, the National Association of Attorneys General, led by its 2025 President, New Hampshire Attorney General John Formella, hosted the Presidential Initiative Summit in Portsmouth, New Hampshire. General...more

Rivkin Radler LLP

DEA Announces New Telemedicine Rules Expanding Access to Controlled Substances

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On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more

Jones Day

DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

Jones Day on

The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more

Morgan Lewis

DEA Proposed Telemedicine Prescribing Rule Could Burden Hospice Physicians and Hospice Operations

Morgan Lewis on

Signaling a possible future approach to regulating Schedule II-V prescribing via telemedicine in lieu of in-person examinations, on January 17 the DEA issued a notice of proposed rulemaking regarding its next iteration of...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

DLA Piper on

On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

Bennett Jones LLP

Supreme Court of Canada Endorses Comity in Class Proceedings in Response to the Opioid Epidemic

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A national class action on behalf of multiple Canadian governments to recover opioid epidemic healthcare costs simplifies the aggregation, prosecution, and determination of claims that span geographic boundaries. That is what...more

Polsinelli

Santa is Bringing Long-Awaited Regulatory Changes to Massachusetts Pharmacy Licensure

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After almost a decade of waiting, Massachusetts has announced that it will open its licensing process for non-resident pharmacies. Yesterday, the Massachusetts Board of Registration in Pharmacy published a memo announcing...more

Quarles & Brady LLP

Are You Ready for Massachusetts Non-Resident Pharmacy Licensure?

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On November 19, 2024, the Massachusetts Board of Registration in Pharmacy (the “Board”) published several memoranda that described the impending non-resident pharmacy licensure requirements and the anticipated timeline for...more

Ropes & Gray LLP

[Podcast] Controlling Opinions: Navigating DEA Diversion Investigations

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On this episode of Ropes & Gray’s podcast series Controlling Opinions, Josh Oyster, a partner in the life sciences regulatory and compliance practice group, is joined by colleagues Andrew O’Connor, a litigation and...more

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

Bradley Arant Boult Cummings LLP

MDMA DOA at FDA Advisory Committee

Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

Troutman Pepper Locke

Reassessing Oregon’s Drug Policy: A Shift Toward Recriminalization

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In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more

Cozen O'Connor

CVS Settles with Alaska AG for $10 Million over Opioid Allegations

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Alaska AG Treg Taylor has reached a settlement with CVS Pharmacy, Inc. to resolve allegations that the company violated Alaska’s Unfair Trade Practices and Consumer Protection Act by allegedly dispensing opioid-containing...more

Faegre Drinker Biddle & Reath LLP

Remote Prescribing of Controlled Substances via Telehealth: Stakeholders Urge DEA to Address Geographic Red Flag for Pharmacists

Due to convenience and effectiveness, patients are increasingly seeking care via telehealth, including for conditions that require treatment with medication. During the pandemic, patients gained access to telehealth for...more

Quarles & Brady LLP

It's (Apparently) Never Too Late Part II: DEA & Morris & Dickson Settle

Quarles & Brady LLP on

This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

Quarles & Brady LLP on

On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

Napoli Shkolnik

The Opioid Crisis and Pharma Accountability: The Road So Far

Napoli Shkolnik on

In 2020, over 142 million prescriptions for opioid medications were filled in the U.S. That same year, 16,416 people died from overdoses on prescription opioids—a 376% increase from 1999....more

Alston & Bird

Health Care Week in Review: New House Speaker Elected; HRSA Issued a Notice on 340B Drug Pricing Program Requirements

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Pullman & Comley - Connecticut Health Law

DEA Extension of Telemedicine Flexibilities and Impact on CT Practitioners

On October 10, 2023, the federal Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) published a new temporary rule which extends, through December 31, 2024, the ability of ...more

Bass, Berry & Sims PLC

Extension Extended: DEA Continues Telemedicine Prescription Flexibilities Through 2024

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On October 6, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule providing for a second temporary extension of its COVID-19 telemedicine...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

Final Rule to Allow for "One-Time Only" Transfer of Electronic Controlled Substance Prescriptions Between Pharmacies

Bass, Berry & Sims PLC on

On August 28, 2023, amendments to Drug Enforcement Agency (DEA) regulation 21 CFR 1306.08 will go into effect, which amend the regulations allowing the transfer of initial electronic prescriptions for schedule II-V 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

Quarles & Brady LLP

It's (Apparently) Never Too Late: DEA’s Revocation of Morris & Dickson’s Registrations

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On May 26, 2023, the Drug Enforcement Administration (DEA) published a final decision and order (the “Final Order”) affirming an Administrative Law Judge's (ALJ) August 29, 2019 recommendation (the “ALJ Order”) to revoke DEA...more

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