News & Analysis as of

Controlled Substances Act Compliance

ArentFox Schiff

Top 10 Issues in the Cannabis Industry for 2025

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It is not all doom and gloom for the cannabis industry this year; positive developments across states and the potential (albeit remote) for federal rescheduling means the cannabis industry can expect ongoing advancements....more

Frantz Ward LLP

Proposed Senate Bill 86 Seeks to Regulate Hemp Beverages and Intoxicating Hemp Products Differently

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Ohio lawmakers are moving to tighten hemp regulations following Governor Mike DeWine’s call to “regulate intoxicating hemp” and close legal gaps that may allow the marketing and sale of hemp products to minors. Senators Shane...more

Foley & Lardner LLP

DEA Unveils Long-Overdue Special Registration for Telemedicine in Proposed Rule

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In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners with a Special Registration to prescribe Schedule III-V, and in limited...more

Mintz - Health Care Viewpoints

EnforceMintz — Novel Criminal Charges and Emerging Civil Trends from Opioid Enforcement in 2024

In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more

Foley & Lardner LLP

DEA Tightens Buprenorphine Telemedicine Prescribing Rules

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The Drug Enforcement Administration (DEA) and the U.S. Department of Health & Human Services (HHS) just finalized their March 2023 proposed rule regarding telemedicine prescribing of buprenorphine. The final rule, effective...more

Goodwin

DEA Announces a Third Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

Goodwin on

On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more

McGlinchey Stafford

Rescheduling Marijuana FAQs: Cannabis-Related Investments

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On May 21, 2024, the Drug Enforcement Agency (DEA) filed the Proposed Rule to move marijuana from Schedule I of the Controlled Substances Act (CSA) to Schedule III of the CSA. In light of the rescheduling marijuana news,...more

Benesch

FMCSR Waivers and Exemptions - Game Plan When You Can’t Strictly Comply

Benesch on

Public safety on the roadways is the chief objective of the Federal Motor Carrier Safety Regulations (FMCSRs). Some safety and operations teams will from time to time encounter unique circumstances where strict compliance can...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

Farella Braun + Martel LLP

A Simpler Approach To Expanding Banking Access

While the cannabis community anxiously awaits what feels like Congress’ hundredth attempt to pass the SAFE Banking Act, there is one simple step that can be taken today to improve access to banking services for certain...more

Bradley Arant Boult Cummings LLP

Does the End Justify the Means? Privacy Advocates React to the Cooper Davis Act

This summer, a proposed amendment to the Controlled Substances Act known as the Cooper Davis Act (the “Act”) is making its way through congressional approvals and causing growing dissension between and among parents, consumer...more

Foley & Lardner LLP

Regulatory Alert: DEA’s New Controlled Substance Theft or Loss Rule Includes a New Deadline and May Require Changes to Corporate...

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On July 24, 2023, a new final rule from the Drug Enforcement Administration (DEA) became effective, with important consequences for companies and individuals registered to manufacture, distribute, or dispense 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

Venable LLP

Marijuana Banking in 2022: Lessons Learned and Best Practices

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​​​​​​​As we pass the halfway mark of 2022, it's a good time to reflect on what has happened, or not happened, with respect to the legal framework for the provision of financial services to marijuana-related businesses...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 30, Number 32. News Briefs: September 2021

Report on Medicare Compliance 30, no. 32 (September 13, 2021) - Saint Francis Medical Center in Missouri agreed to pay $1.625 million in a civil settlement of allegations it violated the Controlled Substances Act, the...more

Mitchell, Williams, Selig, Gates & Woodyard,...

The High Points: SARs and the Three Tiered Framework for MRBs

As green states continue to grow, intentional or unintentional exposure to Marijuana Related Business (“MRB”) customers for financial institutions and broker-dealers is an inevitability. Whether your business has decided to...more

Oberheiden P.C.

Pharmacy Compliance: Will Your Pharmacy’s Policies and Protocols Withstand a DEA or PBM Audit?

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Compliance is a key aspect of operating a successful pharmacy in the United States. This is true for pharmacies that bill federal healthcare benefit programs (i.e. Medicare, Medicaid, and Tricare) and private payors, and it...more

Health Care Compliance Association (HCCA)

With Telehealth on OIG Work Plan, Beware Pitfalls; CMS Proposes HHA Telehealth Past PHE

Report on Medicare Compliance 29, no. 25 (July 13, 2020)  - When a physician’s telehealth visit with a Medicare patient on FaceTime cut out after five minutes, they shifted to an audio-only visit, with the physician and...more

Woods Rogers

Part 2: United States Department of Agriculture Publishes Interim Final Rule on Domestic Hemp Production

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Part II - This article is the second in a three-part series discussing the United States Department of Agriculture’s (USDA) Interim Final Rule on the establishment of a domestic hemp production program recently published...more

Carlton Fields

Canna We Talk Cannabis? Emerging Topics in Cannabis Law

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The cannabis industry is rapidly expanding in the United States, with multiple jurisdictions and corporations seeking to accommodate the evolving cannabis market. Carlton Fields attorneys Kevin McCoy and Jennifer Tschetter...more

Harris Beach Murtha PLLC

Two Executives and Distributor Charged for Unlawfully Distributing Controlled Substances

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

The Volkov Law Group

U.S. Marijuana Laws Cause Uncertainty for Financial Institutions

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The quasi-legal status of marijuana in today’s United States is raising serious questions about federalism and enforcement for U.S. financial institutions. It is well known that marijuana is still classified as a Schedule I...more

Troutman Pepper

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

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The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

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