News & Analysis as of

Physicians Prescription Drugs Pharmacies

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

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For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Dinsmore & Shohl LLP

Mixing Medicine and Risk: Ohio’s Joint Regulatory Statement Targets Retail IV Therapy Clinics

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On May 15, 2025, the State Medical Board of Ohio, the Ohio Board of Pharmacy and the Ohio Board of Nursing (collectively, the “Boards”) jointly issued a significant regulatory statement (the “Statement”) clarifying the legal...more

Bradley Arant Boult Cummings LLP

DEA Proposed Rule for Special Registrations for Telemedicine and Limited State Telemedicine Registrations

On January 17, 2025, the Drug Enforcement Administration (DEA) released the proposed rule, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations.” The proposed rule marks a significant first...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

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Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

Rivkin Radler LLP

Court: Mailing Drugs to Patients’ Homes is a Potential Stark Law Violation

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A recently issued federal court opinion confirmed that certain pre-COVID era prescribing restrictions are back in place. In July 2023, a nonprofit advocacy group, Community Oncology Alliance, filed suit against the U.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

Quarles & Brady LLP

New California Law Affects Pharmacy Operations, Staffing Ratios, And Much More

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On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and...more

Husch Blackwell LLP

Proposed Regulation Permits Massachusetts Pharmacists to Prescribe Hormonal Contraceptives

Husch Blackwell LLP on

During the October 11, 2023, Massachusetts Public Health Council Meeting, staff representing the Department of Public Health’s Drug Control Program introduced proposed revisions to 105 CMR 700.000: Implementation of M.G.L....more

Morris James LLP

Prescription Errors

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Prescription errors, unfortunately, are common. Every year, 7,000 to 9,000 people die as a result of medication errors in the United States, making it the third most common cause of death in the country after heart disease...more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

Oberheiden P.C. on

Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

Bass, Berry & Sims PLC

Summary of Medicare Drug Negotiation Program in Inflation Reduction Act and Impact on Pharmacies and Providers

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The U.S. House of Representatives is expected today to pass legislation passed by the U.S. Senate that will significantly alter the landscape for pharmaceutical pricing and reimbursement under the Medicare program for certain...more

Robinson+Cole Health Law Diagnosis

Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more

MoFo Life Sciences

New Jersey Court Affirms Prohibition Of Physician Practice From Opening And Operating In-Office Pharmacy

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At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to...more

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

Better Healthcare Newsletter from Patrick Malone - December 2021

In this season of goodwill, gratitude, and giving, it's worth considering that both friends and strangers can have medical needs that we can ease with little pain or inconvenience to ourselves. Here's a sampling of five ways...more

Bass, Berry & Sims PLC

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

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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

McDermott Will & Schulte

340B in 2021: What Covered Entities and Their Partners Need to Know Now

Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of...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

McDermott Will & Schulte

[Webinar] 340B in 2021: What Covered Entities and Their Partners Need to Know Now - March 18th, 2:00 pm - 3:00 pm ET

This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow. Our...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

Epstein Becker & Green

Finalized HHS Drug Formulary Rebate Rule Faces Uncertain Future Under Biden Administration and Current Legal Challenge

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On November 30, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a final rule (“Final Rule”) that removes safe harbor protection under the discount safe harbor to...more

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

U.S. suit accuses Walmart of fueling deadly opioid crisis via its pharmacies

The stain of the nation’s opioid abuse and drug overdose crisis has spread now to Bentonville, Ark., as federal prosecutors have sued Walmart, accusing the nation’s largest retailer of improperly allowing its pharmacists to...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

Health Care Compliance Association (HCCA)

CMS Hikes Payment for COVID-19 Inpatients Treated With New Drugs, Links it to 20% Bonus

Report on Medicare Compliance 29, no. 39 (November 2, 2020) - CMS said Oct. 28 that Medicare will pay hospitals extra when they treat inpatients with drugs or biologicals approved by the Food and Drug Administration (FDA)...more

Smart & Biggar

Health Canada amends Drug Sampling Laws and issues Guidance (effective July 1, 2020)

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Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For...more

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