News & Analysis as of

Controlled Substances Prescription Drugs Pharmacies

McGuireWoods LLP

Pharmacist Has Key Role in Assessing “Legitimate Medical Purpose” of Controlled Substance Prescriptions

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Federal Controlled Substance Act regulations require that prescriptions for controlled substances be issued only for legitimate medical purposes by individual practitioners acting in their usual course of professional...more

Robinson+Cole Health Law Diagnosis

False Claims Act Enforcement of Pharmacy Pricing & Prescribing Practices: The Walgreens Cases

The Department of Justice has launched a number of enforcement actions targeting pharmacies for alleged violations of the False Claims Act (FCA). Recently, Walgreens has been the subject of two noteworthy government...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

BakerHostetler

Make no mistake, pharmacies can still deliver controlled substances to patients

BakerHostetler on

Under the federal Controlled Substances Act (CSA) and the Drug Enforcement Administration’s (DEA) implementing regulations, pharmacies must deliver controlled substances to the ultimate user. Common sense, as well as DEA’s...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

Napoli Shkolnik

The Opioid Crisis and Pharma Accountability: The Road So Far

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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

Polsinelli

DEA Issues Second Temporary Rule Extending Controlled Substance Prescribing Flexibilities Through December 2024

Polsinelli on

On October 6, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a Second Temporary Rule, further extending the ability to prescribe controlled substances via telemedicine...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

Holland & Knight LLP on

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

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

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

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

Patrick Malone & Associates P.C. | DC Injury...

Nation’s biggest drug stores seek to settle opioid suits for $10 billion

While critics keep throwing up a false narrative about “ambulance chasing,” self-enriching lawyers, their labors and the civil legal system have proven yet again their effectiveness in wringing financial justice for those...more

Bass, Berry & Sims PLC

Kentucky Federal Court Temporarily Bars CVS from Imposing Block on Interventional Pain Doctor’s Prescriptions

Bass, Berry & Sims PLC on

In mid-August, the Eastern District of Kentucky granted a preliminary injunction in favor of an interventional pain management physician (Physician) against CVS Pharmacy (CVS) based on allegations that CVS was refusing to...more

Patrick Malone & Associates P.C. | DC Injury...

U.S. ends confusion and expands prescribing of opioid-fighting medication

Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine,...more

Pullman & Comley - Connecticut Health Law

Post-Public Health Emergency – Connecticut Pharmacy Limitation Changes

Connecticut has recently notified pharmacies and prescribing providers that various quantity limits and refill criteria will revert back to pre-COVID 19 requirements come May 21, 2021. The reinstatement of pre-COVID 19...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

Patrick Malone & Associates P.C. | DC Injury...

Consultant to pay $573.9 million as consequence of its sketchy opioid advice

The opioid abuse and drug overdose crisis has tarred yet another of the nation’s business titans: McKinsey, a globally renowned consulting firm, has discovered that providing corporate clients sketchy advice about addictive,...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Drug Enforcement Administration Updates Form 222

In 2019, the Drug Enforcement Administration (“DEA”) amended its regulations to implement a single sheet format to its Form 222 replacing the triplicate form currently used. Form 222 is used by DEA registrants to order...more

Hinshaw & Culbertson - Health Care

Attention Pharmacies and Prescribers: New California Controlled Substances Prescription Form and CURES Reporting Requirements Are...

Compliance with prescription drug controlled substances prescribing and dispensing rules is essential for pharmacies and prescribers, as penalties for non-compliance are severe and can result in State Board of Pharmacy and...more

Smart & Biggar

Special Access Program and Emergency Drug Release Program amendments in force

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On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

Harris Beach Murtha PLLC

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

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

Smart & Biggar

From regulatory flexibility to reimbursement changes, how Canadian regulators and payers are managing the COVID-19 crisis

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UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more

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